PsiDeR trial open label extension: Longer-term feasibility, safety and effects of psilocybin on psychiatric symptoms and wellbeing in patients with treatment resistant depression
Abstract
Psilocybin (4-phosphoryloxyl-N,N-dimethyltryptamine), a natural tryptamine occurring in psilocybe mushrooms, has shown promise in the treatment of major depressive disorder (MDD). The Psilocybin in Depression Resistant to standard treatments (PsiDeR) trial was a two arm, double-blind, randomised, placebo-controlled phase 2 trial evaluating feasibility and safety of 25mg psilocybin versus placebo in adults with treatment resistant depression (TRD). Participants were followed-up over 6 weeks after dosing. At the end of the double-blind period, all participants were given the option to enter an open label extension (OLE), where they would receive 25mg psilocybin and the same assessments and psychological support as in the double-blind trial, but followed up over 12 weeks. Inclusion criteria for the OLE were informed consent and the absence of the development of any exclusion criteria as defined for the main trial. This analysis will assess feasibility, safety and effects on psychiatric symptoms and wellbeing in patients who enrolled in the OLE, over 12 weeks. Effects will also be explored in those who received placebo or psilocybin in the RCT phase and enrolled in the OLE phase (i.e., one or two doses of psilocybin overall).
Topics & conditions
Detected automatically by Psychedelic Commons from the title and abstract, not labels from the source. They may be incomplete.
Psychedelic Commons aggregates metadata from open sources and links back to the original. Rights remain with the authors and publishers. Something wrong with this record? Report a problem.