Depression

TOPLINE:

Mental health distress increased disproportionately among transgender and gender-nonconforming US adults between 2014 and 2021 compared with their cisgender counterparts, a new study suggested. Investigators said the findings among an historically marginalized segment of society point to a need to address a growing inequality in mental health.

METHODOLOGY:

• Investigators drew on 2014-2021 US Behavioral Risk Factor Surveillance System (BRFSS) survey data, using logistic and ordinary least squares regression to document temporal trends in the transgender-cisgender disparity in self-reports of the number of poor mental health days in the past month and frequent mental distress.
• They included 43 states that implemented the optional sexual orientation and gender identity module in the BRFSS.
• Outcomes included the number of poor mental health days in the past month, as well as frequent mental distress (≥ 14 poor mental health days in the past month).

TAKEAWAY:

• Even in 2014, there was a discrepancy between cisgender and transgender and gender-nonconforming individuals in the reported mean of poor mental health days (3.68 vs 5.42).
• The size of this disparity, adjusted by differences in observable characteristics, increased by 2.75 days (95% CI, 0.58-4.91) over the study period.
• The inequality in mental health status between cisgender and transgender and nonconforming adults grew from 11.4% vs 18.9% in 2014, respectively, to 14.6% vs 32.9% in 2021, respectively.

IN PRACTICE:

“Our findings demonstrate sizable and worsening inequities in mental health across gender identity,” the authors wrote. “Mental health and primary care providers must be prepared to address the unique psychosocial needs of gender minority adults. Furthermore, our findings highlight the need for action to reduce these disparities.”

SOURCE:

Samuel Mann, PhD, of the RAND Corporation, was the corresponding author of the study. It was published online on April 10 in the American Journal of Public Health.

LIMITATIONS:

Measures of mental health were derived from self-reports. In addition, data from seven states were missing because these states did not include sexual orientation and gender identity in the BRFSS. And the BRFSS does not survey people who are unhoused, incarcerated, or in group living quarters.

DISCLOSURES:

No source of study funding was listed. The authors disclosed no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Mental health distress increased disproportionately among transgender and gender-nonconforming US adults between 2014 and 2021 compared with their cisgender counterparts, a new study suggested. Investigators said the findings among an historically marginalized segment of society point to a need to address a growing inequality in mental health.

METHODOLOGY:

• Investigators drew on 2014-2021 US Behavioral Risk Factor Surveillance System (BRFSS) survey data, using logistic and ordinary least squares regression to document temporal trends in the transgender-cisgender disparity in self-reports of the number of poor mental health days in the past month and frequent mental distress.
• They included 43 states that implemented the optional sexual orientation and gender identity module in the BRFSS.
• Outcomes included the number of poor mental health days in the past month, as well as frequent mental distress (≥ 14 poor mental health days in the past month).

TAKEAWAY:

• Even in 2014, there was a discrepancy between cisgender and transgender and gender-nonconforming individuals in the reported mean of poor mental health days (3.68 vs 5.42).
• The size of this disparity, adjusted by differences in observable characteristics, increased by 2.75 days (95% CI, 0.58-4.91) over the study period.
• The inequality in mental health status between cisgender and transgender and nonconforming adults grew from 11.4% vs 18.9% in 2014, respectively, to 14.6% vs 32.9% in 2021, respectively.

IN PRACTICE:

“Our findings demonstrate sizable and worsening inequities in mental health across gender identity,” the authors wrote. “Mental health and primary care providers must be prepared to address the unique psychosocial needs of gender minority adults. Furthermore, our findings highlight the need for action to reduce these disparities.”

SOURCE:

Samuel Mann, PhD, of the RAND Corporation, was the corresponding author of the study. It was published online on April 10 in the American Journal of Public Health.

LIMITATIONS:

Measures of mental health were derived from self-reports. In addition, data from seven states were missing because these states did not include sexual orientation and gender identity in the BRFSS. And the BRFSS does not survey people who are unhoused, incarcerated, or in group living quarters.

DISCLOSURES:

No source of study funding was listed. The authors disclosed no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Mental health distress increased disproportionately among transgender and gender-nonconforming US adults between 2014 and 2021 compared with their cisgender counterparts, a new study suggested. Investigators said the findings among an historically marginalized segment of society point to a need to address a growing inequality in mental health.

METHODOLOGY:

• Investigators drew on 2014-2021 US Behavioral Risk Factor Surveillance System (BRFSS) survey data, using logistic and ordinary least squares regression to document temporal trends in the transgender-cisgender disparity in self-reports of the number of poor mental health days in the past month and frequent mental distress.
• They included 43 states that implemented the optional sexual orientation and gender identity module in the BRFSS.
• Outcomes included the number of poor mental health days in the past month, as well as frequent mental distress (≥ 14 poor mental health days in the past month).

TAKEAWAY:

• Even in 2014, there was a discrepancy between cisgender and transgender and gender-nonconforming individuals in the reported mean of poor mental health days (3.68 vs 5.42).
• The size of this disparity, adjusted by differences in observable characteristics, increased by 2.75 days (95% CI, 0.58-4.91) over the study period.
• The inequality in mental health status between cisgender and transgender and nonconforming adults grew from 11.4% vs 18.9% in 2014, respectively, to 14.6% vs 32.9% in 2021, respectively.

IN PRACTICE:

“Our findings demonstrate sizable and worsening inequities in mental health across gender identity,” the authors wrote. “Mental health and primary care providers must be prepared to address the unique psychosocial needs of gender minority adults. Furthermore, our findings highlight the need for action to reduce these disparities.”

SOURCE:

Samuel Mann, PhD, of the RAND Corporation, was the corresponding author of the study. It was published online on April 10 in the American Journal of Public Health.

LIMITATIONS:

Measures of mental health were derived from self-reports. In addition, data from seven states were missing because these states did not include sexual orientation and gender identity in the BRFSS. And the BRFSS does not survey people who are unhoused, incarcerated, or in group living quarters.

DISCLOSURES:

No source of study funding was listed. The authors disclosed no relevant financial relationships.
 

A version of this article appeared on Medscape.com.

The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week. 

First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.

How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry? 

Why Reschedule? Why Now? 

The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III. 

DEA defines Schedule I drugs as those with no currently accepted medical use and a high potential for abuse. That class includes heroin, LSD, and ecstasy. Schedule III drugs have a moderate to low potential for physical and psychological dependence and have a currently accepted medical use. This class includes ketamine, acetaminophen with codeine, and buprenorphine. 

Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.

Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports. 

Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.

“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization. 

How Does Rescheduling Work? What’s the Timeline?

The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear. 

Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.

“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”

A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.

How Will Rescheduling Affect Medical Marijuana?

For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said. 

“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.

Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use. 

“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.

But what about patients living in states that have not legalized medical cannabis? 

“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.” 

The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.

What Does It Mean for Medical Marijuana Dispensaries?

Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.

“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said. 

“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.

However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.

“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said. 

Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said. 

“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.

Will Rescheduling Make It Easier to Conduct Cannabis-Related Research? 

Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.

“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said. 

The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition. 

In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds. 

It’s unclear whether those guidelines would be updated if the rescheduling moves forward. 

Does Rescheduling Marijuana Pose Any Risk? 

In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”

That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said. 

“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”

Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia. 

“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”

Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness. 

“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”

Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week. 

First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.

How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry? 

Why Reschedule? Why Now? 

The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III. 

DEA defines Schedule I drugs as those with no currently accepted medical use and a high potential for abuse. That class includes heroin, LSD, and ecstasy. Schedule III drugs have a moderate to low potential for physical and psychological dependence and have a currently accepted medical use. This class includes ketamine, acetaminophen with codeine, and buprenorphine. 

Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.

Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports. 

Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.

“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization. 

How Does Rescheduling Work? What’s the Timeline?

The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear. 

Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.

“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”

A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.

How Will Rescheduling Affect Medical Marijuana?

For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said. 

“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.

Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use. 

“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.

But what about patients living in states that have not legalized medical cannabis? 

“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.” 

The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.

What Does It Mean for Medical Marijuana Dispensaries?

Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.

“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said. 

“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.

However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.

“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said. 

Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said. 

“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.

Will Rescheduling Make It Easier to Conduct Cannabis-Related Research? 

Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.

“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said. 

The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition. 

In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds. 

It’s unclear whether those guidelines would be updated if the rescheduling moves forward. 

Does Rescheduling Marijuana Pose Any Risk? 

In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”

That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said. 

“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”

Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia. 

“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”

Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness. 

“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”

Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

The US Drug Enforcement Agency (DEA) is moving forward with plans to move marijuana from a Schedule I to a Schedule III controlled substance under the Controlled Substance Act (CSA), the US Department of Justice officials announced this week. 

First reported by the Associated Press and since confirmed by this news organization through a US Department of Justice spokesperson, the news made international headlines. Despite the media splash, the final rule is still months away.

How did we get here? What happens next? What impact might rescheduling have on clinicians, patients, researchers, and the medical cannabis industry? 

Why Reschedule? Why Now? 

The DEA’s decision is based on a 2023 determination from the US Food and Drug Administration (FDA) that marijuana has a legitimate medical use and should be moved to Schedule III. 

DEA defines Schedule I drugs as those with no currently accepted medical use and a high potential for abuse. That class includes heroin, LSD, and ecstasy. Schedule III drugs have a moderate to low potential for physical and psychological dependence and have a currently accepted medical use. This class includes ketamine, acetaminophen with codeine, and buprenorphine. 

Even though the manufacturing, distribution, sale, and use of marijuana has long violated federal law, 38 states and Washington, DC, have legalized medical cannabis, and 24 states and DC have legalized its recreational use.

Congress has allowed states leeway for the distribution and use of medical marijuana, and current and previous presidential administrations have chosen not to aggressively pursue prosecution of state-allowed marijuana use, the Congressional Research Service (CRS) reports. 

Pressure to address the conflict between federal and state laws and an increasing interest in drug development of cannabis and cannabis-derived products probably contributed to the DEA’s decision, said Stephen Strakowski, MD, professor, and vice chair of psychiatry at Indiana University in Indianapolis, and professor and associate vice president at University of Texas in Austin.

“The trend toward legalization is everywhere and even though nationally the feds in this instance are lagging the states, the pressure to legalize has been intense for 50 years and it’s not surprising that the DEA is finally following that lead,” Dr. Strakowski told this news organization. 

How Does Rescheduling Work? What’s the Timeline?

The DEA will submit a formal rule proposing that marijuana be moved from Schedule I to Schedule III to the White House Office of Management and Budget. The timing of the submission is unclear. 

Once the proposed rule is posted to the Federal Register, there will be a public comment period, which usually lasts 30-60 days.

“This will likely generate a lot of public comment,” Robert Mikos, JD, LaRoche Family Chair in Law at Vanderbilt University Law School in Nashville, Tennessee, told this news organization. “Then the agency has to go back and wade through those comments and decide if they want to proceed with the rule as proposed or modify it.”

A final rule will probably be posted before the end of the current presidential term in January, Mr. Mikos said. While a lawsuit blocking its implementation is possible, there is a “low chance that a court would block this,” he added.

How Will Rescheduling Affect Medical Marijuana?

For medical marijuana, changing the drug to a Schedule III means that it can legally be prescribed but only in states that have legalized medical cannabis, Mr. Mikos said. 

“If you’re a patient in a state with a medical marijuana law and your physician gives you a prescription for medical marijuana and you possess it, you will no longer be guilty of a federal crime,” he said.

Rescheduling could also benefit patients who receive care through the Veterans Administration (VA), Mr. Mikos said. For several years, the VA has had a policy that blocked clinicians from prescribing medical marijuana because as a Schedule I drug, it was determined to have no accepted medical use. 

“It’s possible the VA may drop that policy once the drug gets rescheduled. If you’re in a medical marijuana state, if you’re a VA patient, and you don’t want to spend the extra money to go outside that system, this will have meaningful impact on their lives,” Mr. Mikos said.

But what about patients living in states that have not legalized medical cannabis? 

“You still wouldn’t be committing a federal crime, but you could be violating state law,” Mr. Mikos said. “That’s a much more salient consideration because if you look at who goes after individuals who possess small amounts of drugs, the state handles 99% of those cases.” 

The manufacture, distribution, and possession of recreational marijuana would remain illegal under federal law.

What Does It Mean for Medical Marijuana Dispensaries?

Though rescheduling makes it legal for clinicians to prescribe medical marijuana and for patients to use it, the actual sale of the drug will remain illegal under federal law because rescheduling only changes prescribing under the CSA, Mr. Mikos said.

“If you’re a dispensary and you sell it, even if it’s to somebody who’s got a prescription, you’re still probably violating the Food, Drug and Cosmetics Act. Rescheduling doesn’t change that,” he said. 

“Even assuming the DEA follows through with this and it doesn’t come undone at some future date, the industry is still going struggle to comply with the Controlled Substances Act post rescheduling because that statute is going to continue to impose a number of regulations on the industry,” Mr. Mikos added.

However, rescheduling would change the tax status of the estimated 12,000-15,000 state-licensed cannabis dispensaries in the United States, allowing access to certain tax deductions that are unavailable to sales involving Schedule I controlled substances, James Daily, JD, MS, with Center for Empirical Research in the Law at Washington University School of Law in St. Louis, told this news organization.

“Many cannabis businesses do in fact pay federal taxes, but the inability to take any federal tax credits or deductions means that their effective tax rate is much higher than it would otherwise be,” Mr. Daily said. 

Although new federal tax deductions would likely available to cannabis businesses if marijuana were rescheduled to Schedule III, “their business would still be in violation of federal law,” he said. 

“This creates a further tension between state and federal law, which could be resolved by further legalization or it could be resolved by extending the prohibition on tax deductions to include cannabis and not just Schedule I and II drugs,” he added.

Will Rescheduling Make It Easier to Conduct Cannabis-Related Research? 

Research on medical cannabis has been stymied by FDA and DEA regulations regarding the study of Schedule I controlled substances. Although rescheduling could lift that barrier, other challenges would remain.

“Schedule III drugs can be more easily researched, but it’s unclear if, for example, a clinical trial could lawfully obtain the cannabis from a dispensary or if they would still have to go through the one legal federal supplier of cannabis,” Daily said. 

The FDA reports having received more than 800 investigational new drug applications for and pre-investigational new drug applications related to cannabis and cannabis-derived products since the 1970s, the agency reports. To date, the FDA has not approved any marketing drug applications for cannabis for the treatment of any disease or condition. 

In January 2023, the agency published updated guidelines for researchers and sponsors interested in developing drugs containing cannabis or cannabis-derived compounds. 

It’s unclear whether those guidelines would be updated if the rescheduling moves forward. 

Does Rescheduling Marijuana Pose Any Risk? 

In its report to the DEA that marijuana be rescheduled, the FDA was careful to note that the agency’s recommendation is “not meant to imply that safety and effectiveness have been established for marijuana that would support FDA approval of a marijuana drug product for a particular indication.”

That’s a notation that clinicians and patients should take to heart, Dr. Strakowski said. 

“It’s important to remind people that Schedule III drugs, by definition, have addiction and other side effect risks,” he said. “The celebrity marketing that sits behind a lot of this is incompletely informed. It’s portrayed as fun and harmless in almost every movie and conversation you see, and we know that’s not true.”

Previous studies have linked cannabis to increased risk for mania, anxiety disorders, and schizophrenia. 

“It is increasingly clear that marijuana use is linked to poor outcomes in people who struggle with mental illness,” Dr. Strakowski said. “We have no evidence that it can help you but there is evidence that it can harm you.”

Dr. Strakowski likens cannabis use to alcohol, which is a known depressant that is associated with worse outcomes in people with mental illness. 

“I think with cannabis, we don’t know enough about it yet, but we do know that it does have some anxiety risks,” he said. “The risks in people with mental illness are simply different than in people who don’t have mental illness.”

Dr. Strakowski, Mr. Mikos, and Mr. Daily report no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

DENVER — Among patients with major depressive disorder, transcranial magnetic stimulation (TMS) had similar efficacy to electroconvulsive therapy (ECT), according to results from a retrospective study of patients treated in the past 20 years.

“We always learn in our textbooks that after about two or three medication trials is when you can start exploring more serious treatment protocols, such as ECT or TMS, but a lot of these patients weren’t going forward with it, and I was curious about it. I figured that TMS, which is a less expensive, less scary procedure that patients would more likely be open to, that is also approved for treatment resistant depression, would be a good alternative to ECT,” said Anuttham Kandhadai, a third-year medical student at University of Texas Medical Branch at Galveston, who presented the study at the 2024 annual meeting of the American Academy of Neurology.
 

Study Findings Lead to More Questions

The researchers found lower rates of depressive episodes, suicidal attempts, and suicidal ideation among patients treated with TMS, but an important limitation was that the researchers did not know the severity of the depression in the two patient groups, according to Branch Coslett, MD, who attended the session and has performed research with TMS to treat aphasia in stroke patients. “I think it’s a very interesting study, and certainly something worth pursuing, but given that ECT is only used as a last resort, whereas TMS is often used as a second-line therapy, I think you’re really talking about very different populations that have had these treatments,” said Dr. Coslett.

Mr. Kandhadai recognized the limitations of the study and looks forward to expanding the research. “I’d love to explore cost effectiveness of the treatments. I’d love to explore patient familiarity and patient comfort with different treatments. And I’d also love to explore a more controlled study that can determine how severe someone’s depression is, and then be able to control for that and explore the outcomes based on the treatment protocol,” he said.

The ideal comparative study would be prospective, “but that will never be done. One Flew Over the Cuckoo’s Nest and similar sources of information have really poisoned the well,” said Dr. Coslett. However, he noted that advances have been made in ECT, and that targeting the right hemisphere produces fewer side effects: “The outcomes from unilateral right hemisphere stimulation are said to be every bit as good or maybe better, and you don’t get the confusion, you don’t get the memory loss, you don’t get all that sort of stuff that you’d expect when somebody has a prolonged, generalized tonic-clonic seizure.”

Still, people are naturally reluctant to undergo ECT. “I’ve seen it. It’s pretty barbaric. It’s better now and at my institution, people do get it, but they really, really have to be intractable,” he said.
 

Comparing Treatment Options

Mr. Kandhadai and his co-authors used the TriNetX database to identify patients with treatment-resistant major depressive disorder who received TMS or ECT in the past 20 years. There were 2,916 patients in both cohorts, who were matched by age, sex, ethnicity, mood and behavioral disorders, endocrine disorders, intellectual disabilities, cerebrovascular disease, and other nervous system disorders. The mean age at treatment was 48.2 years, 38.5% were male, and 3.1% were Black or African American.

Short-term outcomes favored TMS, including the frequency of disorientation (0.41% vs 2.81%), retrograde amnesia (0.34% vs 0.65%), and headache (4.36% vs 7.20%). Long-term outcomes from 1 month to 5 years post treatment were also better in the TMS group, including depressive episodes (44.99% vs 53.77%), suicide attempts (3.98% vs 6.86%), and suicidal ideation (12.38% vs 23.49%). Kaplan-Meier curve analysis between 1 month and 5 years showed a benefit to TMS in probability of not experiencing a depressive episode, and not experiencing suicidal ideation.

“ECT has been the gold standard of treatment resistant depression for a long time, and it deserves to be. I think it’s something you should offer your patients. Not everyone might be comfortable with it, and if they’re not, I think it’s important to not stop the conversation there, but to offer something like TMS because TMS is something that might be more accessible to patients. It might be more affordable, and it might be less scary,” said Mr. Kandhadai

Mr. Kandhadai and Dr. Coslett have no relevant financial disclosures.

DENVER — Among patients with major depressive disorder, transcranial magnetic stimulation (TMS) had similar efficacy to electroconvulsive therapy (ECT), according to results from a retrospective study of patients treated in the past 20 years.

“We always learn in our textbooks that after about two or three medication trials is when you can start exploring more serious treatment protocols, such as ECT or TMS, but a lot of these patients weren’t going forward with it, and I was curious about it. I figured that TMS, which is a less expensive, less scary procedure that patients would more likely be open to, that is also approved for treatment resistant depression, would be a good alternative to ECT,” said Anuttham Kandhadai, a third-year medical student at University of Texas Medical Branch at Galveston, who presented the study at the 2024 annual meeting of the American Academy of Neurology.
 

Study Findings Lead to More Questions

The researchers found lower rates of depressive episodes, suicidal attempts, and suicidal ideation among patients treated with TMS, but an important limitation was that the researchers did not know the severity of the depression in the two patient groups, according to Branch Coslett, MD, who attended the session and has performed research with TMS to treat aphasia in stroke patients. “I think it’s a very interesting study, and certainly something worth pursuing, but given that ECT is only used as a last resort, whereas TMS is often used as a second-line therapy, I think you’re really talking about very different populations that have had these treatments,” said Dr. Coslett.

Mr. Kandhadai recognized the limitations of the study and looks forward to expanding the research. “I’d love to explore cost effectiveness of the treatments. I’d love to explore patient familiarity and patient comfort with different treatments. And I’d also love to explore a more controlled study that can determine how severe someone’s depression is, and then be able to control for that and explore the outcomes based on the treatment protocol,” he said.

The ideal comparative study would be prospective, “but that will never be done. One Flew Over the Cuckoo’s Nest and similar sources of information have really poisoned the well,” said Dr. Coslett. However, he noted that advances have been made in ECT, and that targeting the right hemisphere produces fewer side effects: “The outcomes from unilateral right hemisphere stimulation are said to be every bit as good or maybe better, and you don’t get the confusion, you don’t get the memory loss, you don’t get all that sort of stuff that you’d expect when somebody has a prolonged, generalized tonic-clonic seizure.”

Still, people are naturally reluctant to undergo ECT. “I’ve seen it. It’s pretty barbaric. It’s better now and at my institution, people do get it, but they really, really have to be intractable,” he said.
 

Comparing Treatment Options

Mr. Kandhadai and his co-authors used the TriNetX database to identify patients with treatment-resistant major depressive disorder who received TMS or ECT in the past 20 years. There were 2,916 patients in both cohorts, who were matched by age, sex, ethnicity, mood and behavioral disorders, endocrine disorders, intellectual disabilities, cerebrovascular disease, and other nervous system disorders. The mean age at treatment was 48.2 years, 38.5% were male, and 3.1% were Black or African American.

Short-term outcomes favored TMS, including the frequency of disorientation (0.41% vs 2.81%), retrograde amnesia (0.34% vs 0.65%), and headache (4.36% vs 7.20%). Long-term outcomes from 1 month to 5 years post treatment were also better in the TMS group, including depressive episodes (44.99% vs 53.77%), suicide attempts (3.98% vs 6.86%), and suicidal ideation (12.38% vs 23.49%). Kaplan-Meier curve analysis between 1 month and 5 years showed a benefit to TMS in probability of not experiencing a depressive episode, and not experiencing suicidal ideation.

“ECT has been the gold standard of treatment resistant depression for a long time, and it deserves to be. I think it’s something you should offer your patients. Not everyone might be comfortable with it, and if they’re not, I think it’s important to not stop the conversation there, but to offer something like TMS because TMS is something that might be more accessible to patients. It might be more affordable, and it might be less scary,” said Mr. Kandhadai

Mr. Kandhadai and Dr. Coslett have no relevant financial disclosures.

DENVER — Among patients with major depressive disorder, transcranial magnetic stimulation (TMS) had similar efficacy to electroconvulsive therapy (ECT), according to results from a retrospective study of patients treated in the past 20 years.

“We always learn in our textbooks that after about two or three medication trials is when you can start exploring more serious treatment protocols, such as ECT or TMS, but a lot of these patients weren’t going forward with it, and I was curious about it. I figured that TMS, which is a less expensive, less scary procedure that patients would more likely be open to, that is also approved for treatment resistant depression, would be a good alternative to ECT,” said Anuttham Kandhadai, a third-year medical student at University of Texas Medical Branch at Galveston, who presented the study at the 2024 annual meeting of the American Academy of Neurology.
 

Study Findings Lead to More Questions

The researchers found lower rates of depressive episodes, suicidal attempts, and suicidal ideation among patients treated with TMS, but an important limitation was that the researchers did not know the severity of the depression in the two patient groups, according to Branch Coslett, MD, who attended the session and has performed research with TMS to treat aphasia in stroke patients. “I think it’s a very interesting study, and certainly something worth pursuing, but given that ECT is only used as a last resort, whereas TMS is often used as a second-line therapy, I think you’re really talking about very different populations that have had these treatments,” said Dr. Coslett.

Mr. Kandhadai recognized the limitations of the study and looks forward to expanding the research. “I’d love to explore cost effectiveness of the treatments. I’d love to explore patient familiarity and patient comfort with different treatments. And I’d also love to explore a more controlled study that can determine how severe someone’s depression is, and then be able to control for that and explore the outcomes based on the treatment protocol,” he said.

The ideal comparative study would be prospective, “but that will never be done. One Flew Over the Cuckoo’s Nest and similar sources of information have really poisoned the well,” said Dr. Coslett. However, he noted that advances have been made in ECT, and that targeting the right hemisphere produces fewer side effects: “The outcomes from unilateral right hemisphere stimulation are said to be every bit as good or maybe better, and you don’t get the confusion, you don’t get the memory loss, you don’t get all that sort of stuff that you’d expect when somebody has a prolonged, generalized tonic-clonic seizure.”

Still, people are naturally reluctant to undergo ECT. “I’ve seen it. It’s pretty barbaric. It’s better now and at my institution, people do get it, but they really, really have to be intractable,” he said.
 

Comparing Treatment Options

Mr. Kandhadai and his co-authors used the TriNetX database to identify patients with treatment-resistant major depressive disorder who received TMS or ECT in the past 20 years. There were 2,916 patients in both cohorts, who were matched by age, sex, ethnicity, mood and behavioral disorders, endocrine disorders, intellectual disabilities, cerebrovascular disease, and other nervous system disorders. The mean age at treatment was 48.2 years, 38.5% were male, and 3.1% were Black or African American.

Short-term outcomes favored TMS, including the frequency of disorientation (0.41% vs 2.81%), retrograde amnesia (0.34% vs 0.65%), and headache (4.36% vs 7.20%). Long-term outcomes from 1 month to 5 years post treatment were also better in the TMS group, including depressive episodes (44.99% vs 53.77%), suicide attempts (3.98% vs 6.86%), and suicidal ideation (12.38% vs 23.49%). Kaplan-Meier curve analysis between 1 month and 5 years showed a benefit to TMS in probability of not experiencing a depressive episode, and not experiencing suicidal ideation.

“ECT has been the gold standard of treatment resistant depression for a long time, and it deserves to be. I think it’s something you should offer your patients. Not everyone might be comfortable with it, and if they’re not, I think it’s important to not stop the conversation there, but to offer something like TMS because TMS is something that might be more accessible to patients. It might be more affordable, and it might be less scary,” said Mr. Kandhadai

Mr. Kandhadai and Dr. Coslett have no relevant financial disclosures.

Most people experiencing homelessness have mental health disorders, according to a systematic review and meta-analysis.

In an examination of studies that included nearly 50,000 participants, the current prevalence of mental health disorders among people experiencing homelessness was 67% and the lifetime prevalence was 77%.

“The relationship is likely bidirectional, where experiencing homelessness may exacerbate mental health symptoms or where having a mental health disorder may increase an individual’s risk for experiencing homelessness,” lead author Rebecca Barry, PhD, a postdoctoral fellow at the University of Calgary in Calgary, Alberta, Canada, told this news organization. 

“There are also likely stressors that increase both risk for homelessness and risk for developing mental health disorders. This study examines prevalence but does not examine causal relationships,” she said.

The findings were published in JAMA Psychiatry.
 

A Growing Problem 

To determine the current and lifetime prevalence of mental health disorders among the homeless population, the researchers analyzed 85 studies that examined this question in participants aged ≥ 18 years. The review included 48,414 participants, including 11,154 (23%) women and 37,260 (77%) men.

The lifetime prevalence of mental health disorders was significantly higher in men experiencing homelessness (86%) than in women (69%). The most common mental health disorder was substance use disorder (44%), followed by antisocial personality disorder (26%), major depression (19%), bipolar disorder (8%), and schizophrenia (7%).

The prevalence of current and lifetime mental health disorders among the homeless population was higher than that that observed in the general population (13%-15% and 12%-47%, respectively).

The results resembled those of a previous review that estimated that 76% of people experiencing homelessness living in high-income countries have mental health disorders.

“Even though our results are not surprising, they still are drawing attention to this issue because it is a big problem in Canada, the United States, Europe, and other places,” senior author Dallas Seitz, MD, PhD, professor of psychiatry at the University of Calgary’s Cumming School of Medicine, told this news organization. “The problem is concerning, and it’s not getting better. Addiction and mental health problems are becoming more common among people who are homeless.” 

The bottom line is that people need affordable housing and mental health support, said Dr. Seitz. “It’s a housing problem and a health problem, and we need adequate resources to find better ways for those two systems to collaborate. There are public safety concerns, and we have to try and bring services to people experiencing homelessness. You have to come and meet people where they’re at. You have to try and establish a trusting relationship so that we can get people on the path to recovery.”
 

‘It’s Really About Income’ 

Commenting on the findings for this news organization, Stephen Hwang, MD, professor of medicine at the University of Toronto, Toronto, Ontario, Canada, said, “There have been previous studies of this type, but it is good to have an updated one.” Dr. Hwang, who is also chair in Homelessness, Housing, and Health at St. Michael’s Hospital, did not participate in the research. 

The findings must be understood in the proper context, he added. For one thing, grouping together all mental health disorders and giving a single prevalence figure can be misleading. “They are including in that category a diverse group of conditions. Substance use disorder, personality disorder, schizophrenia, and depression are all lumped together. The 67% prevalence seems very high, but it is a combination of many different conditions. I just don’t want people to look at that number and think that this means that everyone is a substance user or everyone has schizophrenia,” said Dr. Hwang. 

Also, some readers might interpret the findings to mean that mental problems are the reason people are homeless, he added. “That would be an incorrect interpretation because what this study is showing is that people with mental health disorders have a higher risk for becoming homeless. It doesn’t mean that it caused their homelessness. What really causes homelessness is a lack of affordable housing,” said Dr. Hwang.

“In a city or community where housing is very expensive, there’s not enough for everyone to be housed, there is a lot of competition for housing, and there’s not enough affordable housing for a number of reasons, we know that people with mental health conditions and substance use disorders will be among the first to lose their housing,” he said.

“It’s really about income. There are many reasons why a person cannot afford housing. So, not being able to earn enough money to afford it because you have a mental health disorder or substance use disorder is a common underlying reason for homelessness.”

Dr. Hwang also pointed out that people with mental illness who can access support, either through family members or through mental health care, and who also have the income to afford such services do not become homeless.

“Schizophrenia is seen in every population of the world at a rate of 1%. But you travel to certain cities and you see people who appear to have schizophrenia wandering the streets, and you go to other cities in the world and you don’t see anyone who looks like they’re homeless and have schizophrenia,” he said. 

“It’s not because there are fewer people with schizophrenia in those cities or countries; it’s because people with schizophrenia are treated differently. The rate of homelessness is determined not by how many people have that condition [eg, schizophrenia] but by how we treat those people and how we set up our society to either support or not support people who have disabilities.”

The study was funded by the Precision Care With Information, Science and Experience – Mental Health grant funded by the Calgary Health Foundation. Dr. Barry is supported by the Harley Hotchkiss Samuel Weiss Postdoctoral Fellowship awarded by the Hotchkiss Brain Institute at the University of Calgary. Dr. Barry reported having no relevant financial relationships. Dr. Seitz reported grants from Calgary Health Foundation during the conduct of the study as well as grants from University Health Foundation, the Canadian Institutes of Health Research, the Public Health Agency of Canada, the Alzheimer’s Association, and the Hotchkiss Brain Institute. He received honoraria for guideline development from the Canadian Coalition for Seniors Mental Health outside the submitted work. Dr. Hwang reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Most people experiencing homelessness have mental health disorders, according to a systematic review and meta-analysis.

In an examination of studies that included nearly 50,000 participants, the current prevalence of mental health disorders among people experiencing homelessness was 67% and the lifetime prevalence was 77%.

“The relationship is likely bidirectional, where experiencing homelessness may exacerbate mental health symptoms or where having a mental health disorder may increase an individual’s risk for experiencing homelessness,” lead author Rebecca Barry, PhD, a postdoctoral fellow at the University of Calgary in Calgary, Alberta, Canada, told this news organization. 

“There are also likely stressors that increase both risk for homelessness and risk for developing mental health disorders. This study examines prevalence but does not examine causal relationships,” she said.

The findings were published in JAMA Psychiatry.
 

A Growing Problem 

To determine the current and lifetime prevalence of mental health disorders among the homeless population, the researchers analyzed 85 studies that examined this question in participants aged ≥ 18 years. The review included 48,414 participants, including 11,154 (23%) women and 37,260 (77%) men.

The lifetime prevalence of mental health disorders was significantly higher in men experiencing homelessness (86%) than in women (69%). The most common mental health disorder was substance use disorder (44%), followed by antisocial personality disorder (26%), major depression (19%), bipolar disorder (8%), and schizophrenia (7%).

The prevalence of current and lifetime mental health disorders among the homeless population was higher than that that observed in the general population (13%-15% and 12%-47%, respectively).

The results resembled those of a previous review that estimated that 76% of people experiencing homelessness living in high-income countries have mental health disorders.

“Even though our results are not surprising, they still are drawing attention to this issue because it is a big problem in Canada, the United States, Europe, and other places,” senior author Dallas Seitz, MD, PhD, professor of psychiatry at the University of Calgary’s Cumming School of Medicine, told this news organization. “The problem is concerning, and it’s not getting better. Addiction and mental health problems are becoming more common among people who are homeless.” 

The bottom line is that people need affordable housing and mental health support, said Dr. Seitz. “It’s a housing problem and a health problem, and we need adequate resources to find better ways for those two systems to collaborate. There are public safety concerns, and we have to try and bring services to people experiencing homelessness. You have to come and meet people where they’re at. You have to try and establish a trusting relationship so that we can get people on the path to recovery.”
 

‘It’s Really About Income’ 

Commenting on the findings for this news organization, Stephen Hwang, MD, professor of medicine at the University of Toronto, Toronto, Ontario, Canada, said, “There have been previous studies of this type, but it is good to have an updated one.” Dr. Hwang, who is also chair in Homelessness, Housing, and Health at St. Michael’s Hospital, did not participate in the research. 

The findings must be understood in the proper context, he added. For one thing, grouping together all mental health disorders and giving a single prevalence figure can be misleading. “They are including in that category a diverse group of conditions. Substance use disorder, personality disorder, schizophrenia, and depression are all lumped together. The 67% prevalence seems very high, but it is a combination of many different conditions. I just don’t want people to look at that number and think that this means that everyone is a substance user or everyone has schizophrenia,” said Dr. Hwang. 

Also, some readers might interpret the findings to mean that mental problems are the reason people are homeless, he added. “That would be an incorrect interpretation because what this study is showing is that people with mental health disorders have a higher risk for becoming homeless. It doesn’t mean that it caused their homelessness. What really causes homelessness is a lack of affordable housing,” said Dr. Hwang.

“In a city or community where housing is very expensive, there’s not enough for everyone to be housed, there is a lot of competition for housing, and there’s not enough affordable housing for a number of reasons, we know that people with mental health conditions and substance use disorders will be among the first to lose their housing,” he said.

“It’s really about income. There are many reasons why a person cannot afford housing. So, not being able to earn enough money to afford it because you have a mental health disorder or substance use disorder is a common underlying reason for homelessness.”

Dr. Hwang also pointed out that people with mental illness who can access support, either through family members or through mental health care, and who also have the income to afford such services do not become homeless.

“Schizophrenia is seen in every population of the world at a rate of 1%. But you travel to certain cities and you see people who appear to have schizophrenia wandering the streets, and you go to other cities in the world and you don’t see anyone who looks like they’re homeless and have schizophrenia,” he said. 

“It’s not because there are fewer people with schizophrenia in those cities or countries; it’s because people with schizophrenia are treated differently. The rate of homelessness is determined not by how many people have that condition [eg, schizophrenia] but by how we treat those people and how we set up our society to either support or not support people who have disabilities.”

The study was funded by the Precision Care With Information, Science and Experience – Mental Health grant funded by the Calgary Health Foundation. Dr. Barry is supported by the Harley Hotchkiss Samuel Weiss Postdoctoral Fellowship awarded by the Hotchkiss Brain Institute at the University of Calgary. Dr. Barry reported having no relevant financial relationships. Dr. Seitz reported grants from Calgary Health Foundation during the conduct of the study as well as grants from University Health Foundation, the Canadian Institutes of Health Research, the Public Health Agency of Canada, the Alzheimer’s Association, and the Hotchkiss Brain Institute. He received honoraria for guideline development from the Canadian Coalition for Seniors Mental Health outside the submitted work. Dr. Hwang reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Most people experiencing homelessness have mental health disorders, according to a systematic review and meta-analysis.

In an examination of studies that included nearly 50,000 participants, the current prevalence of mental health disorders among people experiencing homelessness was 67% and the lifetime prevalence was 77%.

“The relationship is likely bidirectional, where experiencing homelessness may exacerbate mental health symptoms or where having a mental health disorder may increase an individual’s risk for experiencing homelessness,” lead author Rebecca Barry, PhD, a postdoctoral fellow at the University of Calgary in Calgary, Alberta, Canada, told this news organization. 

“There are also likely stressors that increase both risk for homelessness and risk for developing mental health disorders. This study examines prevalence but does not examine causal relationships,” she said.

The findings were published in JAMA Psychiatry.
 

A Growing Problem 

To determine the current and lifetime prevalence of mental health disorders among the homeless population, the researchers analyzed 85 studies that examined this question in participants aged ≥ 18 years. The review included 48,414 participants, including 11,154 (23%) women and 37,260 (77%) men.

The lifetime prevalence of mental health disorders was significantly higher in men experiencing homelessness (86%) than in women (69%). The most common mental health disorder was substance use disorder (44%), followed by antisocial personality disorder (26%), major depression (19%), bipolar disorder (8%), and schizophrenia (7%).

The prevalence of current and lifetime mental health disorders among the homeless population was higher than that that observed in the general population (13%-15% and 12%-47%, respectively).

The results resembled those of a previous review that estimated that 76% of people experiencing homelessness living in high-income countries have mental health disorders.

“Even though our results are not surprising, they still are drawing attention to this issue because it is a big problem in Canada, the United States, Europe, and other places,” senior author Dallas Seitz, MD, PhD, professor of psychiatry at the University of Calgary’s Cumming School of Medicine, told this news organization. “The problem is concerning, and it’s not getting better. Addiction and mental health problems are becoming more common among people who are homeless.” 

The bottom line is that people need affordable housing and mental health support, said Dr. Seitz. “It’s a housing problem and a health problem, and we need adequate resources to find better ways for those two systems to collaborate. There are public safety concerns, and we have to try and bring services to people experiencing homelessness. You have to come and meet people where they’re at. You have to try and establish a trusting relationship so that we can get people on the path to recovery.”
 

‘It’s Really About Income’ 

Commenting on the findings for this news organization, Stephen Hwang, MD, professor of medicine at the University of Toronto, Toronto, Ontario, Canada, said, “There have been previous studies of this type, but it is good to have an updated one.” Dr. Hwang, who is also chair in Homelessness, Housing, and Health at St. Michael’s Hospital, did not participate in the research. 

The findings must be understood in the proper context, he added. For one thing, grouping together all mental health disorders and giving a single prevalence figure can be misleading. “They are including in that category a diverse group of conditions. Substance use disorder, personality disorder, schizophrenia, and depression are all lumped together. The 67% prevalence seems very high, but it is a combination of many different conditions. I just don’t want people to look at that number and think that this means that everyone is a substance user or everyone has schizophrenia,” said Dr. Hwang. 

Also, some readers might interpret the findings to mean that mental problems are the reason people are homeless, he added. “That would be an incorrect interpretation because what this study is showing is that people with mental health disorders have a higher risk for becoming homeless. It doesn’t mean that it caused their homelessness. What really causes homelessness is a lack of affordable housing,” said Dr. Hwang.

“In a city or community where housing is very expensive, there’s not enough for everyone to be housed, there is a lot of competition for housing, and there’s not enough affordable housing for a number of reasons, we know that people with mental health conditions and substance use disorders will be among the first to lose their housing,” he said.

“It’s really about income. There are many reasons why a person cannot afford housing. So, not being able to earn enough money to afford it because you have a mental health disorder or substance use disorder is a common underlying reason for homelessness.”

Dr. Hwang also pointed out that people with mental illness who can access support, either through family members or through mental health care, and who also have the income to afford such services do not become homeless.

“Schizophrenia is seen in every population of the world at a rate of 1%. But you travel to certain cities and you see people who appear to have schizophrenia wandering the streets, and you go to other cities in the world and you don’t see anyone who looks like they’re homeless and have schizophrenia,” he said. 

“It’s not because there are fewer people with schizophrenia in those cities or countries; it’s because people with schizophrenia are treated differently. The rate of homelessness is determined not by how many people have that condition [eg, schizophrenia] but by how we treat those people and how we set up our society to either support or not support people who have disabilities.”

The study was funded by the Precision Care With Information, Science and Experience – Mental Health grant funded by the Calgary Health Foundation. Dr. Barry is supported by the Harley Hotchkiss Samuel Weiss Postdoctoral Fellowship awarded by the Hotchkiss Brain Institute at the University of Calgary. Dr. Barry reported having no relevant financial relationships. Dr. Seitz reported grants from Calgary Health Foundation during the conduct of the study as well as grants from University Health Foundation, the Canadian Institutes of Health Research, the Public Health Agency of Canada, the Alzheimer’s Association, and the Hotchkiss Brain Institute. He received honoraria for guideline development from the Canadian Coalition for Seniors Mental Health outside the submitted work. Dr. Hwang reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

The number of suicides among US college students has doubled over the past two decades and is now the second-most common cause of death after accidents in this population, a new study by the National Collegiate Athletic Association (NCAA) found.

METHODOLOGY:

• Investigators analyzed deaths between 2002 and 2022, using Poisson regression models to assess changes in incidence rates over time.
• Data were drawn from the NCAA death database, which includes death from any cause, and included demographic characteristics such as age and race and sporting discipline.
• They utilized linear and quadratic fits between year and suicide incidence for men and women.
• Given the low incidence of suicide deaths per year, the incidence rate was multiplied by 100,000 to calculate the incidence per 100,000 athlete-years (AYs).
•  

TAKEAWAY:

• Of 1102 total deaths, 11.6% were due to suicide (98 men, 30 women).
• Athletes who died by suicide ranged in age from 17 to 24 years (mean, 20 years) were predominantly men (77%) and White (59%), with the highest suicide incidence rate among male cross-country athletes (1:29 per 815 AYs).
• The overall incidence of suicide was 1:71 per 145 AYs.
• Over the last 10 years, suicide was the second most common cause of death after accidents, with the proportion of deaths by suicide doubling from the first to the second decades (7.6% to 15.3%).
• Among men, the suicide incidence rate increased in a linear fashion (5-year incidence rate ratio, 1.32; 95% CI, 1.14-1.53), while among women, a quadratic association was identified (P = .002), with the incidence rate reaching its lowest point in women from 2010 to 2011 and increasing thereafter.

IN PRACTICE:

“Athletes are generally thought of as one of the healthiest populations in our society, yet the pressures of school, internal and external performance expectations, time demands, injury, athletic identity, and physical fatigue can lead to depression, mental health problems, and suicide,” the authors wrote. “Although the rate of suicide among collegiate athletes remains lower than the general population, it is important to recognize the parallel increase to ensure this population is not overlooked when assessing for risk factors and implementing prevention strategies.”

SOURCE:

Bridget M. Whelan, MPH, research scientist in the Department of Family Medicine, Sports Medicine Section, University of Washington School of Medicine, Seattle, was the lead and corresponding author on the study, which was published online in the British Journal of Sports Medicine.

LIMITATIONS:

There is no mandatory reporting system for athlete deaths in the United States, and investigators’ search identified 16 deaths with unknown causes, suggesting reported suicide incidence rates may be underestimated. Additionally, in cases of overdose that were not clearly intentional, the death was listed as “overdose,” possibly resulting in underreporting of suicide.

DISCLOSURES:

No source of study funding was listed. The authors disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

The number of suicides among US college students has doubled over the past two decades and is now the second-most common cause of death after accidents in this population, a new study by the National Collegiate Athletic Association (NCAA) found.

METHODOLOGY:

• Investigators analyzed deaths between 2002 and 2022, using Poisson regression models to assess changes in incidence rates over time.
• Data were drawn from the NCAA death database, which includes death from any cause, and included demographic characteristics such as age and race and sporting discipline.
• They utilized linear and quadratic fits between year and suicide incidence for men and women.
• Given the low incidence of suicide deaths per year, the incidence rate was multiplied by 100,000 to calculate the incidence per 100,000 athlete-years (AYs).
•  

TAKEAWAY:

• Of 1102 total deaths, 11.6% were due to suicide (98 men, 30 women).
• Athletes who died by suicide ranged in age from 17 to 24 years (mean, 20 years) were predominantly men (77%) and White (59%), with the highest suicide incidence rate among male cross-country athletes (1:29 per 815 AYs).
• The overall incidence of suicide was 1:71 per 145 AYs.
• Over the last 10 years, suicide was the second most common cause of death after accidents, with the proportion of deaths by suicide doubling from the first to the second decades (7.6% to 15.3%).
• Among men, the suicide incidence rate increased in a linear fashion (5-year incidence rate ratio, 1.32; 95% CI, 1.14-1.53), while among women, a quadratic association was identified (P = .002), with the incidence rate reaching its lowest point in women from 2010 to 2011 and increasing thereafter.

IN PRACTICE:

“Athletes are generally thought of as one of the healthiest populations in our society, yet the pressures of school, internal and external performance expectations, time demands, injury, athletic identity, and physical fatigue can lead to depression, mental health problems, and suicide,” the authors wrote. “Although the rate of suicide among collegiate athletes remains lower than the general population, it is important to recognize the parallel increase to ensure this population is not overlooked when assessing for risk factors and implementing prevention strategies.”

SOURCE:

Bridget M. Whelan, MPH, research scientist in the Department of Family Medicine, Sports Medicine Section, University of Washington School of Medicine, Seattle, was the lead and corresponding author on the study, which was published online in the British Journal of Sports Medicine.

LIMITATIONS:

There is no mandatory reporting system for athlete deaths in the United States, and investigators’ search identified 16 deaths with unknown causes, suggesting reported suicide incidence rates may be underestimated. Additionally, in cases of overdose that were not clearly intentional, the death was listed as “overdose,” possibly resulting in underreporting of suicide.

DISCLOSURES:

No source of study funding was listed. The authors disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

The number of suicides among US college students has doubled over the past two decades and is now the second-most common cause of death after accidents in this population, a new study by the National Collegiate Athletic Association (NCAA) found.

METHODOLOGY:

• Investigators analyzed deaths between 2002 and 2022, using Poisson regression models to assess changes in incidence rates over time.
• Data were drawn from the NCAA death database, which includes death from any cause, and included demographic characteristics such as age and race and sporting discipline.
• They utilized linear and quadratic fits between year and suicide incidence for men and women.
• Given the low incidence of suicide deaths per year, the incidence rate was multiplied by 100,000 to calculate the incidence per 100,000 athlete-years (AYs).
•  

TAKEAWAY:

• Of 1102 total deaths, 11.6% were due to suicide (98 men, 30 women).
• Athletes who died by suicide ranged in age from 17 to 24 years (mean, 20 years) were predominantly men (77%) and White (59%), with the highest suicide incidence rate among male cross-country athletes (1:29 per 815 AYs).
• The overall incidence of suicide was 1:71 per 145 AYs.
• Over the last 10 years, suicide was the second most common cause of death after accidents, with the proportion of deaths by suicide doubling from the first to the second decades (7.6% to 15.3%).
• Among men, the suicide incidence rate increased in a linear fashion (5-year incidence rate ratio, 1.32; 95% CI, 1.14-1.53), while among women, a quadratic association was identified (P = .002), with the incidence rate reaching its lowest point in women from 2010 to 2011 and increasing thereafter.

IN PRACTICE:

“Athletes are generally thought of as one of the healthiest populations in our society, yet the pressures of school, internal and external performance expectations, time demands, injury, athletic identity, and physical fatigue can lead to depression, mental health problems, and suicide,” the authors wrote. “Although the rate of suicide among collegiate athletes remains lower than the general population, it is important to recognize the parallel increase to ensure this population is not overlooked when assessing for risk factors and implementing prevention strategies.”

SOURCE:

Bridget M. Whelan, MPH, research scientist in the Department of Family Medicine, Sports Medicine Section, University of Washington School of Medicine, Seattle, was the lead and corresponding author on the study, which was published online in the British Journal of Sports Medicine.

LIMITATIONS:

There is no mandatory reporting system for athlete deaths in the United States, and investigators’ search identified 16 deaths with unknown causes, suggesting reported suicide incidence rates may be underestimated. Additionally, in cases of overdose that were not clearly intentional, the death was listed as “overdose,” possibly resulting in underreporting of suicide.

DISCLOSURES:

No source of study funding was listed. The authors disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Antidepressants are not associated with an increased risk for dementia, accelerated cognitive decline, or atrophy of white and gray matter in adults with no signs of cognitive impairment, new research suggests.

METHODOLOGY:

• Investigators studied 5511 individuals (58% women; mean age, 71 years) from the Rotterdam study, an ongoing prospective population-based cohort study.
• Participants were free from dementia at baseline, and incident dementia was monitored from baseline until 2018 with repeated cognitive assessments using the Mini-Mental Status Examination (MMSE) and the Geriatric Mental Schedule, as well as MRIs.
• Information on participants’ antidepressant use was extracted from pharmacy records from 1992 until baseline (2002-2008).
• During a mean follow-up of 10 years, 12% of participants developed dementia.

TAKEAWAY:

• Overall, 17% of participants had used antidepressants during the roughly 10-year period prior to baseline, and 4.1% were still using antidepressants at baseline.
• Medication use at baseline was more common in women than in men (21% vs 18%), and use increased with age: From 2.1% in participants aged between 45 and 50 years to 4.5% in those older than 80 years.
• After adjustment for confounders, there was no association between antidepressant use and dementia risk (hazard ratio [HR], 1.14; 95% CI, 0.92-1.41), accelerated cognitive decline, or atrophy of white and gray matter.
• However, tricyclic antidepressant use was associated with increased dementia risk (HR, 1.36; 95% CI, 1.01-1.83) compared with the use of selective serotonin reuptake inhibitors (HR, 1.12; 95% CI, 0.81-1.54).

IN PRACTICE:

“Although prescription of antidepressant medication in older individuals, in particular those with some cognitive impairment, may have acute symptomatic anticholinergic effects that warrant consideration in clinical practice, our results show that long-term antidepressant use does not have lasting effects on cognition or brain health in older adults without indication of cognitive impairment,” the authors wrote.

SOURCE:

Frank J. Wolters, MD, of the Department of Epidemiology and the Department of Radiology and Nuclear Medicine and Alzheimer Center, Erasmus University Medical Center, Rotterdam, the Netherlands, was the senior author on this study that was published online in Alzheimer’s and Dementia.

LIMITATIONS:

Limitations included the concern that although exclusion of participants with MMSE < 26 at baseline prevented reversed causation (ie, antidepressant use in response to depression during the prodromal phase of dementia), it may have introduced selection bias by disregarding the effects of antidepressant use prior to baseline and excluding participants with lower education.

DISCLOSURES:

This study was conducted as part of the Netherlands Consortium of Dementia Cohorts, which receives funding in the context of Deltaplan Dementie from ZonMW Memorabel and Alzheimer Nederland. Further funding was also obtained from the Stichting Erasmus Trustfonds. This study was further supported by a 2020 NARSAD Young Investigator Grant from the Brain & Behavior Research Foundation. The authors reported no conflicts of interest or relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Antidepressants are not associated with an increased risk for dementia, accelerated cognitive decline, or atrophy of white and gray matter in adults with no signs of cognitive impairment, new research suggests.

METHODOLOGY:

• Investigators studied 5511 individuals (58% women; mean age, 71 years) from the Rotterdam study, an ongoing prospective population-based cohort study.
• Participants were free from dementia at baseline, and incident dementia was monitored from baseline until 2018 with repeated cognitive assessments using the Mini-Mental Status Examination (MMSE) and the Geriatric Mental Schedule, as well as MRIs.
• Information on participants’ antidepressant use was extracted from pharmacy records from 1992 until baseline (2002-2008).
• During a mean follow-up of 10 years, 12% of participants developed dementia.

TAKEAWAY:

• Overall, 17% of participants had used antidepressants during the roughly 10-year period prior to baseline, and 4.1% were still using antidepressants at baseline.
• Medication use at baseline was more common in women than in men (21% vs 18%), and use increased with age: From 2.1% in participants aged between 45 and 50 years to 4.5% in those older than 80 years.
• After adjustment for confounders, there was no association between antidepressant use and dementia risk (hazard ratio [HR], 1.14; 95% CI, 0.92-1.41), accelerated cognitive decline, or atrophy of white and gray matter.
• However, tricyclic antidepressant use was associated with increased dementia risk (HR, 1.36; 95% CI, 1.01-1.83) compared with the use of selective serotonin reuptake inhibitors (HR, 1.12; 95% CI, 0.81-1.54).

IN PRACTICE:

“Although prescription of antidepressant medication in older individuals, in particular those with some cognitive impairment, may have acute symptomatic anticholinergic effects that warrant consideration in clinical practice, our results show that long-term antidepressant use does not have lasting effects on cognition or brain health in older adults without indication of cognitive impairment,” the authors wrote.

SOURCE:

Frank J. Wolters, MD, of the Department of Epidemiology and the Department of Radiology and Nuclear Medicine and Alzheimer Center, Erasmus University Medical Center, Rotterdam, the Netherlands, was the senior author on this study that was published online in Alzheimer’s and Dementia.

LIMITATIONS:

Limitations included the concern that although exclusion of participants with MMSE < 26 at baseline prevented reversed causation (ie, antidepressant use in response to depression during the prodromal phase of dementia), it may have introduced selection bias by disregarding the effects of antidepressant use prior to baseline and excluding participants with lower education.

DISCLOSURES:

This study was conducted as part of the Netherlands Consortium of Dementia Cohorts, which receives funding in the context of Deltaplan Dementie from ZonMW Memorabel and Alzheimer Nederland. Further funding was also obtained from the Stichting Erasmus Trustfonds. This study was further supported by a 2020 NARSAD Young Investigator Grant from the Brain & Behavior Research Foundation. The authors reported no conflicts of interest or relevant financial relationships.

A version of this article appeared on Medscape.com.

TOPLINE:

Antidepressants are not associated with an increased risk for dementia, accelerated cognitive decline, or atrophy of white and gray matter in adults with no signs of cognitive impairment, new research suggests.

METHODOLOGY:

• Investigators studied 5511 individuals (58% women; mean age, 71 years) from the Rotterdam study, an ongoing prospective population-based cohort study.
• Participants were free from dementia at baseline, and incident dementia was monitored from baseline until 2018 with repeated cognitive assessments using the Mini-Mental Status Examination (MMSE) and the Geriatric Mental Schedule, as well as MRIs.
• Information on participants’ antidepressant use was extracted from pharmacy records from 1992 until baseline (2002-2008).
• During a mean follow-up of 10 years, 12% of participants developed dementia.

TAKEAWAY:

• Overall, 17% of participants had used antidepressants during the roughly 10-year period prior to baseline, and 4.1% were still using antidepressants at baseline.
• Medication use at baseline was more common in women than in men (21% vs 18%), and use increased with age: From 2.1% in participants aged between 45 and 50 years to 4.5% in those older than 80 years.
• After adjustment for confounders, there was no association between antidepressant use and dementia risk (hazard ratio [HR], 1.14; 95% CI, 0.92-1.41), accelerated cognitive decline, or atrophy of white and gray matter.
• However, tricyclic antidepressant use was associated with increased dementia risk (HR, 1.36; 95% CI, 1.01-1.83) compared with the use of selective serotonin reuptake inhibitors (HR, 1.12; 95% CI, 0.81-1.54).

IN PRACTICE:

“Although prescription of antidepressant medication in older individuals, in particular those with some cognitive impairment, may have acute symptomatic anticholinergic effects that warrant consideration in clinical practice, our results show that long-term antidepressant use does not have lasting effects on cognition or brain health in older adults without indication of cognitive impairment,” the authors wrote.

SOURCE:

Frank J. Wolters, MD, of the Department of Epidemiology and the Department of Radiology and Nuclear Medicine and Alzheimer Center, Erasmus University Medical Center, Rotterdam, the Netherlands, was the senior author on this study that was published online in Alzheimer’s and Dementia.

LIMITATIONS:

Limitations included the concern that although exclusion of participants with MMSE < 26 at baseline prevented reversed causation (ie, antidepressant use in response to depression during the prodromal phase of dementia), it may have introduced selection bias by disregarding the effects of antidepressant use prior to baseline and excluding participants with lower education.

DISCLOSURES:

This study was conducted as part of the Netherlands Consortium of Dementia Cohorts, which receives funding in the context of Deltaplan Dementie from ZonMW Memorabel and Alzheimer Nederland. Further funding was also obtained from the Stichting Erasmus Trustfonds. This study was further supported by a 2020 NARSAD Young Investigator Grant from the Brain & Behavior Research Foundation. The authors reported no conflicts of interest or relevant financial relationships.

A version of this article appeared on Medscape.com.

BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date. During a presentation on April 18 at the annual American College of Physicians Internal Medicine Meeting, Gerald Smetana, MD, professor of medicine in the Division of General Medicine at Beth Israel Deaconess Medical Center in Boston, reviewed four of these new therapies that are likely to be particularly important for primary care clinicians. 

A New First-Line for GERD?

Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD). 

GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.

“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Dr. Smetana told attendees. 

Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.

Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Dr. Smetana said.

Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
 

Nonhormonal Drug for Menopause

Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.

“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Dr. Smetana said.

Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia. 

Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.

“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Dr. Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
 

RSV Vaccine for Everyone 

Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention. 

The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.

Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.

Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.

“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Dr. Smetana said.

As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
 

New Antidepressants

A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.

Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression. 

Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.

“So why is this medication worth discussing now?” Dr. Smetana said. “It’s because the side effect profile is different from existing antidepressants.” 

Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Dr. Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said. 

Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Dr. Smetana said. 

Gepirone will be available to prescribe to patients in fall 2024.

Dr. Smetana reported no relevant financial conflicts of interest. 
 

A version of this article appeared on Medscape.com.

BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date. During a presentation on April 18 at the annual American College of Physicians Internal Medicine Meeting, Gerald Smetana, MD, professor of medicine in the Division of General Medicine at Beth Israel Deaconess Medical Center in Boston, reviewed four of these new therapies that are likely to be particularly important for primary care clinicians. 

A New First-Line for GERD?

Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD). 

GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.

“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Dr. Smetana told attendees. 

Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.

Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Dr. Smetana said.

Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
 

Nonhormonal Drug for Menopause

Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.

“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Dr. Smetana said.

Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia. 

Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.

“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Dr. Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
 

RSV Vaccine for Everyone 

Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention. 

The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.

Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.

Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.

“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Dr. Smetana said.

As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
 

New Antidepressants

A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.

Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression. 

Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.

“So why is this medication worth discussing now?” Dr. Smetana said. “It’s because the side effect profile is different from existing antidepressants.” 

Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Dr. Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said. 

Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Dr. Smetana said. 

Gepirone will be available to prescribe to patients in fall 2024.

Dr. Smetana reported no relevant financial conflicts of interest. 
 

A version of this article appeared on Medscape.com.

BOSTON — The US Food and Drug Administration (FDA) approved 55 new medications in 2023 and 11 more in 2024 to date. During a presentation on April 18 at the annual American College of Physicians Internal Medicine Meeting, Gerald Smetana, MD, professor of medicine in the Division of General Medicine at Beth Israel Deaconess Medical Center in Boston, reviewed four of these new therapies that are likely to be particularly important for primary care clinicians. 

A New First-Line for GERD?

Vonoprazan, an oral potassium-competitive acid blocker — which received FDA approval in November 2023 — may be a good alternative for patients whose symptoms continue to linger despite taking medications designated to treat gastroesophageal reflux disease (GERD). 

GERD is the most common gastrointestinal symptom encountered by primary care physicians. Proton-pump inhibitors (PPIs) are the first-line treatment for the condition but can have long-term side effects such as Clostridioides difficile infection and kidney lesions.

“We know that not all patients are going to have symptom relief with H2 blockers and PPIs, so there’s an opportunity for patients who don’t get full symptom relief,” Dr. Smetana told attendees. 

Vonoprazan blocks potassium binding to ATPase proton pumps and inhibits the secretion of gastric acid.

The approval of vonoprazan for erosive GERD was based on results from the phase 3 PHALCON-EE study, a randomized, double-blind, multicenter study that found the drug to be more effective than lansoprazole in treating erosive esophagitis.

Vonoprazan “has more rapid absorption than PPIs [and a] longer half-life and is more potent than PPIs, so theoretically it could be more effective in certain settings,” Dr. Smetana said.

Vonoprazan is FDA approved for only 6 months of use. Despite its efficacy, cost may be a barrier to many patients. H2 blockers generally cost patients less than $10 for 1 month’s supply, whereas vonoprazan can cost up to $650.
 

Nonhormonal Drug for Menopause

Fezolinetant, the first neurokinin receptor antagonist to receive approval from the FDA to treat vasomotor symptoms, may be an option for women concerned about hormone-based therapy for menopausal hot flashes.

“[Fezolinetant] specifically works in the area of the brain that’s involved in body temperature regulation and sweating,” Dr. Smetana said.

Results from the SKYLIGHT 1 randomized controlled trial of fezolinetant found the medication reduced the frequency and severity of hot flashes. Some of the side effects include abdominal pain, diarrhea, and insomnia. 

Other nonestrogen treatments, including selective serotonin reuptake inhibitors (SSRIs), gabapentin, cognitive-behavioral therapy, and hypnosis, are modestly effective, according to the North American Menopause Society.

“[Fezolinetant] offers a different option that physicians may be more comfortable prescribing,” Dr. Smetana said. “And I think this will be an important addition to nonhormonal therapy.”
 

RSV Vaccine for Everyone 

Once considered an illness that is more prevalent in young children, respiratory syncytial virus (RSV) has become more prevalent and severe among older adults. Between 60,000 and 120,000 older adults are hospitalized and 6000-10,000 die of RSV infection each year, according to the US Centers for Disease Control and Prevention. 

The FDA has approved two RSV vaccines approved for older adults, but clinicians may find it challenging to get older patients vaccinated for this and other preventable illnesses.

Patients who received the RSV vaccine had an 83% relative risk reduction for the illness, according to a recent study, and an overall lower risk for hospitalization.

Moderna is developing an mRNA vaccine for RSV that is similar to many COVID-19 vaccines. A study published in 2023 in The New England Journal of Medicine found no cases of neuroinflammatory disorders among patients who received the mRNA RSV vaccine, with a median follow-up of 112 days.

“This is important given ongoing concerns of neurological safety,” among older adults who receive the RSV vaccine, Dr. Smetana said.

As of March 2024, the CDC recommends shared decision-making for adults older than 60 years and for healthcare providers to “consider” rather than “recommend” the vaccine for their patients. The agency’s Adult RSV Work Group plans to meet at June 2024 to reconsider whether shared clinical decision-making remains the preferred policy option.
 

New Antidepressants

A medication thrice rejected by the FDA is now heading a new class of drugs to treat major depressive disorder.

Gepirone, a 5-HT1A receptor agonist, has a different mechanism of action from that of SSRIs, which are currently considered the first-line treatment for depression. 

Gepirone was rejected by the FDA in 2002, 2004, and 2007, with concerns that the efficacy studies were too small. In 2015, an FDA advisory committee agreed that the evidence to date did not support approval of an extended-release form of the drug. But the agency decided to approve the medication in September 2023.

“So why is this medication worth discussing now?” Dr. Smetana said. “It’s because the side effect profile is different from existing antidepressants.” 

Many patients may stop using SSRIs because of side effects such as insomnia and loss of libido, Dr. Smetana said. Gepirone has the potential to avoid activation of other 5-HT receptors that mediate side effects, he said. 

Studies suggest that gepirone reduces both anxiety and depression scores on the Hamilton Depression Rating Scale in patients who have both conditions and decreases rates of depression relapse compared with placebo through at least 48 weeks. The drug also may be less likely than SSRIs to cause sexual dysfunction in men, Dr. Smetana said. 

Gepirone will be available to prescribe to patients in fall 2024.

Dr. Smetana reported no relevant financial conflicts of interest. 
 

A version of this article appeared on Medscape.com.

Depression is a serious issue. I want to say that off the top, because nothing below is intended to minimize it.

But does everyone need to be tested for it?

A lot of general practices test for it with every patient and every visit. After all, mandates say you have to or you’ll get penalized a few bucks. Since no one wants to leave any money on the table in the razor-thin margins of running a medical practice, they ask these questions (I don’t blame them for that).

I can see where this might be useful, but does it really do much? Or is it just a mandatory waste of time?

Good question.

A recent review by the American College of Physicians found it was mostly a waste of time (which surprises no one). Only one of the eight measures involved in depression screening (suicide risk assessment) turned out to be useful. So, basically, 88% of the time spent on these questions contributed absolutely nothing of clinical relevance.

Of course, this isn’t unique to family medicine. Every time I see a Medicare or Medicare Advantage patient I have to document whether they’ve had flu and pneumonia vaccines. While there are occasional cases where asking about recent vaccines is critical to the history, for most it’s not. But I do it so I don’t get penalized, even though the answer changes nothing. It’s not like I give vaccines in my practice.

A fair number of people come to me for hospital follow-ups, so I go into the system and review the chart. The notes inevitably contain questions of sexual activity, fear of violence, fear of domestic abuse, food security, recent travel patterns, and so on. Some of them are useful in certain situations, but not in all, or even most. All they do is increase the length of the note until anything of relevance is obscured, and allow someone in coding to check the boxes to raise the billing level. Realistically, the ER staff involved probably didn’t ask any of them, and just clicked “no.”

Once this probably seemed like a good idea, but clearly most of it is now a waste of time. These “quality measures” have turned the art of taking a good history into a session of mouse and box clicking.

Does that really improve care?
 

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

Depression is a serious issue. I want to say that off the top, because nothing below is intended to minimize it.

But does everyone need to be tested for it?

A lot of general practices test for it with every patient and every visit. After all, mandates say you have to or you’ll get penalized a few bucks. Since no one wants to leave any money on the table in the razor-thin margins of running a medical practice, they ask these questions (I don’t blame them for that).

I can see where this might be useful, but does it really do much? Or is it just a mandatory waste of time?

Good question.

A recent review by the American College of Physicians found it was mostly a waste of time (which surprises no one). Only one of the eight measures involved in depression screening (suicide risk assessment) turned out to be useful. So, basically, 88% of the time spent on these questions contributed absolutely nothing of clinical relevance.

Of course, this isn’t unique to family medicine. Every time I see a Medicare or Medicare Advantage patient I have to document whether they’ve had flu and pneumonia vaccines. While there are occasional cases where asking about recent vaccines is critical to the history, for most it’s not. But I do it so I don’t get penalized, even though the answer changes nothing. It’s not like I give vaccines in my practice.

A fair number of people come to me for hospital follow-ups, so I go into the system and review the chart. The notes inevitably contain questions of sexual activity, fear of violence, fear of domestic abuse, food security, recent travel patterns, and so on. Some of them are useful in certain situations, but not in all, or even most. All they do is increase the length of the note until anything of relevance is obscured, and allow someone in coding to check the boxes to raise the billing level. Realistically, the ER staff involved probably didn’t ask any of them, and just clicked “no.”

Once this probably seemed like a good idea, but clearly most of it is now a waste of time. These “quality measures” have turned the art of taking a good history into a session of mouse and box clicking.

Does that really improve care?
 

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

Depression is a serious issue. I want to say that off the top, because nothing below is intended to minimize it.

But does everyone need to be tested for it?

A lot of general practices test for it with every patient and every visit. After all, mandates say you have to or you’ll get penalized a few bucks. Since no one wants to leave any money on the table in the razor-thin margins of running a medical practice, they ask these questions (I don’t blame them for that).

I can see where this might be useful, but does it really do much? Or is it just a mandatory waste of time?

Good question.

A recent review by the American College of Physicians found it was mostly a waste of time (which surprises no one). Only one of the eight measures involved in depression screening (suicide risk assessment) turned out to be useful. So, basically, 88% of the time spent on these questions contributed absolutely nothing of clinical relevance.

Of course, this isn’t unique to family medicine. Every time I see a Medicare or Medicare Advantage patient I have to document whether they’ve had flu and pneumonia vaccines. While there are occasional cases where asking about recent vaccines is critical to the history, for most it’s not. But I do it so I don’t get penalized, even though the answer changes nothing. It’s not like I give vaccines in my practice.

A fair number of people come to me for hospital follow-ups, so I go into the system and review the chart. The notes inevitably contain questions of sexual activity, fear of violence, fear of domestic abuse, food security, recent travel patterns, and so on. Some of them are useful in certain situations, but not in all, or even most. All they do is increase the length of the note until anything of relevance is obscured, and allow someone in coding to check the boxes to raise the billing level. Realistically, the ER staff involved probably didn’t ask any of them, and just clicked “no.”

Once this probably seemed like a good idea, but clearly most of it is now a waste of time. These “quality measures” have turned the art of taking a good history into a session of mouse and box clicking.

Does that really improve care?
 

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

BUDAPEST, HUNGARY — Twice daily intranasal oxytocin has been associated with improved social functioning, quality of life, and overall symptoms in adults with autism spectrum disorder (ASD), results of a small randomized control trial showed.

“One of the challenges for adults with autism is experiencing poor social interactions and difficulties in making friends. Insufficient social support from peers, friends, and family members can contribute to loneliness in adolescents with ASD, which in turn leads to anxiety, sadness, and social isolation,” said study investigator Saba Faraji Niri, MD, assistant professor of psychiatry, Tehran University of Medical Sciences in Iran. 

Recent US data show it is relatively common. In addition, previous research suggests intranasal oxytocin significantly increases activity in brain regions that play a role in establishing social interactions.

To evaluate the therapeutic effects and safety of intranasal oxytocin the researchers randomly assigned 39 adult patients with ASD to receive intranasal oxytocin or placebo with 24 units administered every 12 hours for 8 weeks. 

Dr. Faraji Niri said study participants were required to stop all psychotropic medications for at least 8 weeks prior to study entry. 

Participants were assessed at baseline and weeks 4 and 8 using the Autism Quotient, Ritvo Autism Asperger Diagnostic Scale — Revised (RAADS-R), Social Responsiveness Scale (SRS), Clinical Global Impression (CGI) scale, and the World Health Organization Quality of Life-BREF (WHOQL-BREF) questionnaire. Adverse events were also evaluated.

Dr. Faraji Niri said that those receiving intranasal oxytocin showed clinical improvement on RAADS-R scores (P = .010), as well as on the social communication subscale of the SRS (P = .002), the CGI scale (P = .000), and the physical (P = .004), psychological (P = .006), and social relationships (P = .046) domains of the WHOQL-BREF. 

However, although the findings were positive, she said at this point it’s not possible to draw any definitive conclusions. She noted the study had several potential confounders. These included differences in baseline levels of endogenous oxytocin among study participants individuals, as well as difference in required treatment doses, which were adjusted by age and sex. The presence of comorbidities and interactions with other treatments could also affect the results.

Commenting on the findings for this news organization, session chair Szabolcs Kéri, PhD, Professor, Sztárai Institute, University of Tokaj, Sárospatak, Hungary, said the use of oxytocin for ASD is controversial. He said that, while the research contributes to the scientific debate, the clinical significance of the findings is unclear. 

The investigators and Dr Keri reported no relevant financial disclosures.

A version of this article appeared on Medscape.com .

BUDAPEST, HUNGARY — Twice daily intranasal oxytocin has been associated with improved social functioning, quality of life, and overall symptoms in adults with autism spectrum disorder (ASD), results of a small randomized control trial showed.

“One of the challenges for adults with autism is experiencing poor social interactions and difficulties in making friends. Insufficient social support from peers, friends, and family members can contribute to loneliness in adolescents with ASD, which in turn leads to anxiety, sadness, and social isolation,” said study investigator Saba Faraji Niri, MD, assistant professor of psychiatry, Tehran University of Medical Sciences in Iran. 

Recent US data show it is relatively common. In addition, previous research suggests intranasal oxytocin significantly increases activity in brain regions that play a role in establishing social interactions.

To evaluate the therapeutic effects and safety of intranasal oxytocin the researchers randomly assigned 39 adult patients with ASD to receive intranasal oxytocin or placebo with 24 units administered every 12 hours for 8 weeks. 

Dr. Faraji Niri said study participants were required to stop all psychotropic medications for at least 8 weeks prior to study entry. 

Participants were assessed at baseline and weeks 4 and 8 using the Autism Quotient, Ritvo Autism Asperger Diagnostic Scale — Revised (RAADS-R), Social Responsiveness Scale (SRS), Clinical Global Impression (CGI) scale, and the World Health Organization Quality of Life-BREF (WHOQL-BREF) questionnaire. Adverse events were also evaluated.

Dr. Faraji Niri said that those receiving intranasal oxytocin showed clinical improvement on RAADS-R scores (P = .010), as well as on the social communication subscale of the SRS (P = .002), the CGI scale (P = .000), and the physical (P = .004), psychological (P = .006), and social relationships (P = .046) domains of the WHOQL-BREF. 

However, although the findings were positive, she said at this point it’s not possible to draw any definitive conclusions. She noted the study had several potential confounders. These included differences in baseline levels of endogenous oxytocin among study participants individuals, as well as difference in required treatment doses, which were adjusted by age and sex. The presence of comorbidities and interactions with other treatments could also affect the results.

Commenting on the findings for this news organization, session chair Szabolcs Kéri, PhD, Professor, Sztárai Institute, University of Tokaj, Sárospatak, Hungary, said the use of oxytocin for ASD is controversial. He said that, while the research contributes to the scientific debate, the clinical significance of the findings is unclear. 

The investigators and Dr Keri reported no relevant financial disclosures.

A version of this article appeared on Medscape.com .

BUDAPEST, HUNGARY — Twice daily intranasal oxytocin has been associated with improved social functioning, quality of life, and overall symptoms in adults with autism spectrum disorder (ASD), results of a small randomized control trial showed.

“One of the challenges for adults with autism is experiencing poor social interactions and difficulties in making friends. Insufficient social support from peers, friends, and family members can contribute to loneliness in adolescents with ASD, which in turn leads to anxiety, sadness, and social isolation,” said study investigator Saba Faraji Niri, MD, assistant professor of psychiatry, Tehran University of Medical Sciences in Iran. 

Recent US data show it is relatively common. In addition, previous research suggests intranasal oxytocin significantly increases activity in brain regions that play a role in establishing social interactions.

To evaluate the therapeutic effects and safety of intranasal oxytocin the researchers randomly assigned 39 adult patients with ASD to receive intranasal oxytocin or placebo with 24 units administered every 12 hours for 8 weeks. 

Dr. Faraji Niri said study participants were required to stop all psychotropic medications for at least 8 weeks prior to study entry. 

Participants were assessed at baseline and weeks 4 and 8 using the Autism Quotient, Ritvo Autism Asperger Diagnostic Scale — Revised (RAADS-R), Social Responsiveness Scale (SRS), Clinical Global Impression (CGI) scale, and the World Health Organization Quality of Life-BREF (WHOQL-BREF) questionnaire. Adverse events were also evaluated.

Dr. Faraji Niri said that those receiving intranasal oxytocin showed clinical improvement on RAADS-R scores (P = .010), as well as on the social communication subscale of the SRS (P = .002), the CGI scale (P = .000), and the physical (P = .004), psychological (P = .006), and social relationships (P = .046) domains of the WHOQL-BREF. 

However, although the findings were positive, she said at this point it’s not possible to draw any definitive conclusions. She noted the study had several potential confounders. These included differences in baseline levels of endogenous oxytocin among study participants individuals, as well as difference in required treatment doses, which were adjusted by age and sex. The presence of comorbidities and interactions with other treatments could also affect the results.

Commenting on the findings for this news organization, session chair Szabolcs Kéri, PhD, Professor, Sztárai Institute, University of Tokaj, Sárospatak, Hungary, said the use of oxytocin for ASD is controversial. He said that, while the research contributes to the scientific debate, the clinical significance of the findings is unclear. 

The investigators and Dr Keri reported no relevant financial disclosures.

A version of this article appeared on Medscape.com .

SYNLAB and ALCEDIAG recently launched the first blood test to assist in mental health diagnosis in France. The test is aimed at differentiating bipolar disorders from depression. The news may be surprising, given the challenges in diagnosing psychiatric conditions, especially when they share common symptoms such as recurrent depression and bipolar disorder.

Psychiatrists’ reactions to the new test are cautious. Many have echoed the sentiments of the French Association of Biological Psychiatry and Neuropsychopharmacology (AFPBN) and Stéphane Jamain, PhD, director of translational neuropsychiatry research (Inserm U955, Mondor Institute of Biomedical Research), who spoke with this news organization.

Early Diagnosis

Depression and bipolar disorders are two distinct psychiatric illnesses requiring different treatments. Early and accurate diagnosis and appropriate treatment are major challenges for clinicians, especially since untreated or inadequately treated bipolar disorder can lead to significant mental and physical health consequences for patients and their families.

Published studies indicate that it takes an average of 8-10 years, and sometimes even longer, to diagnose bipolar disorder. The diagnosis is based on a psychiatric clinical examination, which is conducted by a specialist using validated questionnaires and evaluation scales.

Early and accurate diagnosis of bipolar disorders that allows for appropriate treatment would be a significant advance for patients and their families. This is what the French laboratories SYNLAB, in partnership with ALCEDIAG, propose through myEDIT-B, a blood test described as “the first validated diagnostic aid test to differentiate depression and bipolar disorders.”

Whether this test, the availability of which has somewhat surprised the psychiatric medical and scientific community, will attract psychiatrists remains to be seen.

The AFPBN stated in a press release that “to date, no test meets conditions for clinical use.” For a diagnostic test to be scientifically valid, ethical, and usable in clinical practice, its development must meet strict criteria, as highlighted by the AFPBN. The approximately 10 criteria include the validation of the scientific results in at least two independent clinical studies or cohorts, satisfactory sensitivity (detection of true positives) and specificity (detection of false negatives), and cost that is ethically responsible and allows patient access, independent of commercial interests.

ALCEDIAG has reported two clinical studies, but only one has been published so far (in Translational Psychiatry) involving 400 patients. In this case, “these patients already had a well-established psychiatric condition, did not quite present the same symptoms between patients with recurrent depression and those with bipolar disorder and were not taking the same treatments,” noted Dr. Jamain.

Differentiating between bipolar disorder and depression is crucial, especially regarding treatments, because antidepressants given to a patient with bipolar disorder can induce a manic shift if they are not accompanied by mood stabilizers, Dr. Jamain acknowledged. Nevertheless, he believes that based on what the laboratory has published, it is difficult to comment on the test at this time.

RNA Editing 

Moreover, myEDIT-B is based on a technique that measures RNA editing modifications of specific markers in patients’ blood, which could lead to differences in amino acids within proteins. The technique is unique to the ALCEDIAG laboratory, which coupled it with an artificial intelligence tool that specifically selected 8 RNA sequences for analysis from thousands of edited sequences to obtain a differential signature for unipolar and bipolar depressions. “This method is niche, the trademark of ALCEDIAG,” said Dr. Jamain, who questions the significance of this “editing” on the periphery of the CNS.

“This technique differs from that adopted by most international consortia, which are very active in this research field. The latter technique compares differences in genome [DNA] nucleotides between individuals in large cohorts involving tens of thousands of people and identifies the most frequently occurring patterns associated with a pathology to deduce a risk of developing a psychiatric illness,” said Jamain. “However, the information provided by these large-scale studies does not allow us to define who is at risk for developing the disease any more than the simple observation of the familial recurrence [heritability] of it does.” 

Scientific Validation 

While ALCEDIAG boasts a sensitivity and specificity of more than 80% for its test, the psychiatric world remains cautious. Interviewed by France Info TV, Marion Leboyer, PhD, general director of the FondaMental Foundation, psychiatrist, and researcher (at AP-HP, Inserm in Créteil, France), highlighted the importance of encouraging research on psychiatric illnesses, especially that which will contribute to the understanding and treatment of patients with bipolar disorders. But she expressed caution regarding the test because of the absence of rigorous scientific validation through clinical trials.

Regarding “ALCEDIAG’s test and its commercial aspect, caution is warranted,” said Dr. Jamain. Only time will tell if psychiatrists will prescribe this €899 test, which currently is not reimbursed by social security (see box below). ALCEDIAG plans to submit a validation dossier to the US Food and Drug Administration.

Test Not Reimbursed by Social Security

The ALCEDIAG test will be available beginning in April 2024, by prescription, in SYNLAB France network laboratories. It is intended for patients aged 18 years and older who are being treated for a moderate or severe depressive episode. Test results are transmitted within 4 weeks to the prescribing psychiatrist, who will confirm the diagnosis to the patient during a consultation. Already available in Italy, this in vitro medical device has a CE-IVD marking. In France, however, it costs €899 and is not reimbursed by social security because of insufficient clinical evidence.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

SYNLAB and ALCEDIAG recently launched the first blood test to assist in mental health diagnosis in France. The test is aimed at differentiating bipolar disorders from depression. The news may be surprising, given the challenges in diagnosing psychiatric conditions, especially when they share common symptoms such as recurrent depression and bipolar disorder.

Psychiatrists’ reactions to the new test are cautious. Many have echoed the sentiments of the French Association of Biological Psychiatry and Neuropsychopharmacology (AFPBN) and Stéphane Jamain, PhD, director of translational neuropsychiatry research (Inserm U955, Mondor Institute of Biomedical Research), who spoke with this news organization.

Early Diagnosis

Depression and bipolar disorders are two distinct psychiatric illnesses requiring different treatments. Early and accurate diagnosis and appropriate treatment are major challenges for clinicians, especially since untreated or inadequately treated bipolar disorder can lead to significant mental and physical health consequences for patients and their families.

Published studies indicate that it takes an average of 8-10 years, and sometimes even longer, to diagnose bipolar disorder. The diagnosis is based on a psychiatric clinical examination, which is conducted by a specialist using validated questionnaires and evaluation scales.

Early and accurate diagnosis of bipolar disorders that allows for appropriate treatment would be a significant advance for patients and their families. This is what the French laboratories SYNLAB, in partnership with ALCEDIAG, propose through myEDIT-B, a blood test described as “the first validated diagnostic aid test to differentiate depression and bipolar disorders.”

Whether this test, the availability of which has somewhat surprised the psychiatric medical and scientific community, will attract psychiatrists remains to be seen.

The AFPBN stated in a press release that “to date, no test meets conditions for clinical use.” For a diagnostic test to be scientifically valid, ethical, and usable in clinical practice, its development must meet strict criteria, as highlighted by the AFPBN. The approximately 10 criteria include the validation of the scientific results in at least two independent clinical studies or cohorts, satisfactory sensitivity (detection of true positives) and specificity (detection of false negatives), and cost that is ethically responsible and allows patient access, independent of commercial interests.

ALCEDIAG has reported two clinical studies, but only one has been published so far (in Translational Psychiatry) involving 400 patients. In this case, “these patients already had a well-established psychiatric condition, did not quite present the same symptoms between patients with recurrent depression and those with bipolar disorder and were not taking the same treatments,” noted Dr. Jamain.

Differentiating between bipolar disorder and depression is crucial, especially regarding treatments, because antidepressants given to a patient with bipolar disorder can induce a manic shift if they are not accompanied by mood stabilizers, Dr. Jamain acknowledged. Nevertheless, he believes that based on what the laboratory has published, it is difficult to comment on the test at this time.

RNA Editing 

Moreover, myEDIT-B is based on a technique that measures RNA editing modifications of specific markers in patients’ blood, which could lead to differences in amino acids within proteins. The technique is unique to the ALCEDIAG laboratory, which coupled it with an artificial intelligence tool that specifically selected 8 RNA sequences for analysis from thousands of edited sequences to obtain a differential signature for unipolar and bipolar depressions. “This method is niche, the trademark of ALCEDIAG,” said Dr. Jamain, who questions the significance of this “editing” on the periphery of the CNS.

“This technique differs from that adopted by most international consortia, which are very active in this research field. The latter technique compares differences in genome [DNA] nucleotides between individuals in large cohorts involving tens of thousands of people and identifies the most frequently occurring patterns associated with a pathology to deduce a risk of developing a psychiatric illness,” said Jamain. “However, the information provided by these large-scale studies does not allow us to define who is at risk for developing the disease any more than the simple observation of the familial recurrence [heritability] of it does.” 

Scientific Validation 

While ALCEDIAG boasts a sensitivity and specificity of more than 80% for its test, the psychiatric world remains cautious. Interviewed by France Info TV, Marion Leboyer, PhD, general director of the FondaMental Foundation, psychiatrist, and researcher (at AP-HP, Inserm in Créteil, France), highlighted the importance of encouraging research on psychiatric illnesses, especially that which will contribute to the understanding and treatment of patients with bipolar disorders. But she expressed caution regarding the test because of the absence of rigorous scientific validation through clinical trials.

Regarding “ALCEDIAG’s test and its commercial aspect, caution is warranted,” said Dr. Jamain. Only time will tell if psychiatrists will prescribe this €899 test, which currently is not reimbursed by social security (see box below). ALCEDIAG plans to submit a validation dossier to the US Food and Drug Administration.

Test Not Reimbursed by Social Security

The ALCEDIAG test will be available beginning in April 2024, by prescription, in SYNLAB France network laboratories. It is intended for patients aged 18 years and older who are being treated for a moderate or severe depressive episode. Test results are transmitted within 4 weeks to the prescribing psychiatrist, who will confirm the diagnosis to the patient during a consultation. Already available in Italy, this in vitro medical device has a CE-IVD marking. In France, however, it costs €899 and is not reimbursed by social security because of insufficient clinical evidence.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

SYNLAB and ALCEDIAG recently launched the first blood test to assist in mental health diagnosis in France. The test is aimed at differentiating bipolar disorders from depression. The news may be surprising, given the challenges in diagnosing psychiatric conditions, especially when they share common symptoms such as recurrent depression and bipolar disorder.

Psychiatrists’ reactions to the new test are cautious. Many have echoed the sentiments of the French Association of Biological Psychiatry and Neuropsychopharmacology (AFPBN) and Stéphane Jamain, PhD, director of translational neuropsychiatry research (Inserm U955, Mondor Institute of Biomedical Research), who spoke with this news organization.

Early Diagnosis

Depression and bipolar disorders are two distinct psychiatric illnesses requiring different treatments. Early and accurate diagnosis and appropriate treatment are major challenges for clinicians, especially since untreated or inadequately treated bipolar disorder can lead to significant mental and physical health consequences for patients and their families.

Published studies indicate that it takes an average of 8-10 years, and sometimes even longer, to diagnose bipolar disorder. The diagnosis is based on a psychiatric clinical examination, which is conducted by a specialist using validated questionnaires and evaluation scales.

Early and accurate diagnosis of bipolar disorders that allows for appropriate treatment would be a significant advance for patients and their families. This is what the French laboratories SYNLAB, in partnership with ALCEDIAG, propose through myEDIT-B, a blood test described as “the first validated diagnostic aid test to differentiate depression and bipolar disorders.”

Whether this test, the availability of which has somewhat surprised the psychiatric medical and scientific community, will attract psychiatrists remains to be seen.

The AFPBN stated in a press release that “to date, no test meets conditions for clinical use.” For a diagnostic test to be scientifically valid, ethical, and usable in clinical practice, its development must meet strict criteria, as highlighted by the AFPBN. The approximately 10 criteria include the validation of the scientific results in at least two independent clinical studies or cohorts, satisfactory sensitivity (detection of true positives) and specificity (detection of false negatives), and cost that is ethically responsible and allows patient access, independent of commercial interests.

ALCEDIAG has reported two clinical studies, but only one has been published so far (in Translational Psychiatry) involving 400 patients. In this case, “these patients already had a well-established psychiatric condition, did not quite present the same symptoms between patients with recurrent depression and those with bipolar disorder and were not taking the same treatments,” noted Dr. Jamain.

Differentiating between bipolar disorder and depression is crucial, especially regarding treatments, because antidepressants given to a patient with bipolar disorder can induce a manic shift if they are not accompanied by mood stabilizers, Dr. Jamain acknowledged. Nevertheless, he believes that based on what the laboratory has published, it is difficult to comment on the test at this time.

RNA Editing 

Moreover, myEDIT-B is based on a technique that measures RNA editing modifications of specific markers in patients’ blood, which could lead to differences in amino acids within proteins. The technique is unique to the ALCEDIAG laboratory, which coupled it with an artificial intelligence tool that specifically selected 8 RNA sequences for analysis from thousands of edited sequences to obtain a differential signature for unipolar and bipolar depressions. “This method is niche, the trademark of ALCEDIAG,” said Dr. Jamain, who questions the significance of this “editing” on the periphery of the CNS.

“This technique differs from that adopted by most international consortia, which are very active in this research field. The latter technique compares differences in genome [DNA] nucleotides between individuals in large cohorts involving tens of thousands of people and identifies the most frequently occurring patterns associated with a pathology to deduce a risk of developing a psychiatric illness,” said Jamain. “However, the information provided by these large-scale studies does not allow us to define who is at risk for developing the disease any more than the simple observation of the familial recurrence [heritability] of it does.” 

Scientific Validation 

While ALCEDIAG boasts a sensitivity and specificity of more than 80% for its test, the psychiatric world remains cautious. Interviewed by France Info TV, Marion Leboyer, PhD, general director of the FondaMental Foundation, psychiatrist, and researcher (at AP-HP, Inserm in Créteil, France), highlighted the importance of encouraging research on psychiatric illnesses, especially that which will contribute to the understanding and treatment of patients with bipolar disorders. But she expressed caution regarding the test because of the absence of rigorous scientific validation through clinical trials.

Regarding “ALCEDIAG’s test and its commercial aspect, caution is warranted,” said Dr. Jamain. Only time will tell if psychiatrists will prescribe this €899 test, which currently is not reimbursed by social security (see box below). ALCEDIAG plans to submit a validation dossier to the US Food and Drug Administration.

Test Not Reimbursed by Social Security

The ALCEDIAG test will be available beginning in April 2024, by prescription, in SYNLAB France network laboratories. It is intended for patients aged 18 years and older who are being treated for a moderate or severe depressive episode. Test results are transmitted within 4 weeks to the prescribing psychiatrist, who will confirm the diagnosis to the patient during a consultation. Already available in Italy, this in vitro medical device has a CE-IVD marking. In France, however, it costs €899 and is not reimbursed by social security because of insufficient clinical evidence.

This story was translated from the Medscape French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.