Med (New York, N.Y.)

Psilocybin-assisted therapy with repeated doses for hard-to-treat depression: A randomized clinical trial

Updated

Abstract

29 out of 30 participants were retained to the week-2 primary endpoint in a study on psilocybin-assisted psychotherapy.

  • Participants with treatment-resistant depression received one to three doses of psilocybin at a fixed dose of 25 mg.
  • Greater reductions in depression severity were observed in the immediate treatment group compared to the waitlist group, with a large effect size of 1.07.
  • Adverse events were transient, and no serious adverse events occurred during the study.
  • Repeated doses of psilocybin were associated with further reductions in depression severity compared to baseline.
  • The study suggests that psilocybin-assisted psychotherapy may be feasible and safe for complex patients with high treatment resistance.

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Funding

Competing interests

Declaration of interests J.D.R. has received research grant support from the Canadian Institute of Health Research (CIHR), Physician Services, Inc. (PSI) Foundation, Labatt Brain Health Network, Brain and Cognition Discovery Foundation (BCDF), Canadian Cancer Society, Canadian Psychiatric Association, Academic Scholars Award, American Psychiatric Association, American Society of Psychopharmacology, University of Toronto, University Health Network Center for Mental Health, Joseph M. West Family Memorial Fund, and Timeposters Fellowship and industry funding for speaker/consultation/research fees from iGan, Boehringer Ingelheim, Janssen, Allergan, Lundbeck, Sunovion, Braxia Health, Braxia Scientific Corp., and COMPASS. R.S.M. has received research grant support from CIHR/GACD/National Natural Science Foundation of China (NSFC), and the Milken Institute and speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, Neurocrine, Neurawell, Sunovion, Bausch Health, Axsome, Novo Nordisk, Kris, Sanofi, Eisai, Intra-Cellular, NewBridge Pharmaceuticals, Viatris, Abbvie, and Atai Life Sciences. R.S.M. is a CEO of Braxia Scientific Corp. C.S.-Q. has received education scholarship support from Academic Scholars Award, Department of Psychiatry, University of Toronto, and Young Leaders Program and Cancer Experience Program, Princess Margaret Cancer Center, University Health Network. He is on the board of directors for the Canadian Academy for Consultation and Liaison Psychiatry. M.G.B. currently works as an independent contractor serving clients for psychedelic-assisted psychotherapy with Braxia Scientific Corp.; in a consulting role, he owns stake in a psychedelic technology company called Entheosense and has received speaking fees as an honorarium for providing a training lecture on psychedelic spiritual care for psychotherapists in this Braxia clinical trial. R.B.M. has received research grant support from the CIHR, the PSI Foundation, and the Baszucki Brain Research Fund and an Academic Scholars Award, Department of Psychiatry, University of Toronto. F.A.G. has received research grant support from the Brain & Behavior Research Foundation (BBRF), Southeastern Ontario Academic Medical Organization (SEAMO), and Queen’s Health Sciences and speaker/consultation fees from Lundbeck, Otsuka, and Abbvie. Z.D., RN, is a clinical project lead with Braxia Scientific Corp. J.B. was a paid co-chair of a psilocybin therapist training event with Braxia Scientific Corp.
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