Docs react: Psychedelic therapy moves closer to clinical reality
Industry Buzz
We desperately need more effective treatments for people living with serious mental health conditions, so accelerating this research is critical to address patient unmet needs. However, accelerating clinical adoption without sufficient evidence for safety and efficacy is not a good idea.
—Manpreet Kaur Singh, MD, Robert H. Putnam Endowed Chair in Bipolar Research and Treatment at University of California
The need for new mental health treatments justifies this new enthusiasm for prioritized review.
—Boris D. Heifets, MD, PhD, associate professor of anesthesiology & perioperative and pain medicine, Stanford University School of Medicine,
President Trump has signed an executive order to accelerate research into and drug approvals of psychedelics for mental health treatment.[]
The order states that the FDA and DEA will establish a pathway for eligible patients to access psychedelic compounds—drugs that have remained controversial for decades.
“The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to specific psychedelic drugs, and there are numerous products currently in the clinical trial pipeline for review of safety and efficacy,” the order states.[]
Here's everything docs need to know to be better equipped to handle the potential influx of questions from interested patients.
Rising interest amid limited evidence
Interest in psychedelic medications in the context of mental health treatment has been growing, but experts warn that for drugs such as ibogaine, research is still limited.
“The recent policy momentum around psychedelics, including ibogaine, reflects both patient need and political advocacy. However, the ibogaine story is a cautionary example because strong anecdotal enthusiasm coexists with limited high-quality data and clear safety concerns,” Manpreet Kaur Singh, MD, the Robert H. Putnam Endowed Chair in Bipolar Research and Treatment at the University of California, Davis, tells MDLinx.
“We desperately need more effective treatments for people living with serious mental health conditions, so accelerating this research is critical to address patient unmet needs. However, accelerating clinical adoption without sufficient evidence for safety and efficacy is not a good idea,” Dr. Singh adds.
Like any other area of novel discovery, especially in cases of high unmet need, we must ensure that the compelling anecdotes, early signals, and rapid enthusiasm are balanced sensibly with establishing safety and using rigorous methods that translate to generating real-world evidence.
—Manpreet Kaur Singh, MD, MS
What's showing promise?
Emerging evidence suggests that psychedelics may be useful in treating a number of psychiatric conditions, including treatment-resistant depression and PTSD.[]
According to Tyler Kjorvestad, MD, a psychiatrist at the University of Kansas Health System, the benefits of psychedelic therapy are "substantial" and well-documented in trials, noting they can deliver rapid symptom relief for many mental health conditions.
In a psilocybin-vs-escitalopram study, patients preserved emotional responsiveness and avoided the emotional blunting and sexual dysfunction common with antidepressants.
—Tyler Kjorvestad, MD, psychiatrist
“Single- or limited-dose regimens offer a streamlined treatment schedule compared with daily medications, fewer chronic side effects, and profound subjective experiences that, when paired with psychotherapy, facilitate lasting psychological insight and behavioral change. For suicidality, these agents show promise in interrupting acute crises and reducing long-term risk,” Dr. Kjorvestad tells MDLinx.
“Single- or limited-dose regimens offer a streamlined treatment schedule compared with daily medications, fewer chronic side effects, and profound subjective experiences that, when paired with psychotherapy, facilitate lasting psychological insight and behavioral change. For suicidality, these agents show promise in interrupting acute crises and reducing long-term risk,” Dr. Kjorvestad adds.
Key Clinical Takeaways
Rapid symptom relief (hours to days) in MDD, treatment-resistant depression, PTSD, and substance use disorders
Increased neuroplasticity
Preserved emotional responsiveness vs SSRI-associated emotional blunting
Lower rates of sexual dysfunction compared with traditional SSRIs
Single- or limited-dose regimens (ie, not daily meds)
Fewer chronic side effects reported in early trials
Facilitates psychological insight and behavioral change when combined with psychotherapy
Potential to interrupt acute suicidal crises and reduce long-term risk
Looking ahead
Associate Professor of Anesthesiology, Perioperative and Pain Medicine and, by courtesy, Psychiatry and Behavioral Sciences at the Stanford University School of Medicine, Boris D. Heifets, MD, PhD, says that while there is more to learn about ibogaine drugs, the need for new treatment options for mental health conditions justifies the acceleration of proper FDA review of psychedelic medications.
“Prioritizing and speeding up impartial full review by the FDA, in my view, is a good thing. Several companies have performed well-designed clinical studies showing promising results, and they deserve a fair hearing. I think the need for new mental health treatments justifies this new enthusiasm for prioritized review,” he tells MDLinx.
“Ibogaine is in a different category than drugs [such as] psilocybin, LSD, and methylone; it has not undergone the same extensive testing in clinical trials yet due to safety concerns. The executive order does not change its legal status, but it seems some top-down pressure has enabled human studies with a derivative of ibogaine to go forward. We have much to learn about this family of drugs,” Dr. Heifets adds.