The New England journal of medicine
November 3, 2022
Guy M Goodwin, Scott T Aaronson, Oscar Alvarez et al.
1,095 citations
A single 25 mg dose of psilocybin, but not 10 mg, reduced depression scores more than a 1 mg control dose over three weeks in adults with treatment-resistant depression. In this phase 2 trial, 233 participants were randomly assigned to 25 mg, 10 mg, or 1 mg of synthetic psilocybin with psychological support. The 25 mg group showed an average 12-point drop on the MADRS depression scale versus a 5.4-point drop in the 1 mg group, a significant difference. The 10 mg group did not differ significantly from control. Response and remission rates at three weeks supported the primary result, but sustained response at 12 weeks was not significantly different.
Frontiers in Psychiatry
February 3, 2021
Sara Tai, Elizabeth M. Nielson, Molly Lennard-Jones et al.
87 citations
A therapist training program for psilocybin therapy, developed for a phase IIb international, multicenter, randomized controlled study of treatment-resistant depression, is described. The manualized approach, based on evidence-based psychotherapeutic methods and approved by the FDA, includes online learning, in-person training, applied clinical training, and ongoing mentoring. After training 65 health care professionals across the US, Canada, and Europe, feedback indicated that didactic and experiential learning helped build conceptual understanding and skills. Clinical training and participant care under experienced therapists were most beneficial and challenging. Rigorous, scalable training requires collaboration among public, academic, and industry partners.
BMJ Open
December 1, 2021
James Rucker, Hassan Jafari, Tim Mantingh et al.
23 citations
A randomized, placebo-controlled trial is testing the feasibility of psilocybin-assisted therapy for people with major depressive disorder who have not responded to at least two prior treatments. Up to 60 participants in London, UK receive either 25 mg psilocybin or a placebo in a single dosing session, along with psychological therapy. The primary outcomes are recruitment rates, dropout rates, and variance in depression scores measured by the Montgomery Asberg Depression Rating Scale at 3 and 6 weeks. The trial also collects neuroimaging and omics data and offers an open-label extension dose of psilocybin.