Psilocybin-assisted therapy for the treatment of resistant major depressive disorder (PsiDeR): protocol for a randomised, placebo-controlled feasibility trial
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.