Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression
Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
The study aims to investigate the safety and efficacy of oral psilocybin administered under
supportive conditions in treatment-resistant major depression (TRD).
The study is a bi-centric, prospective, randomized, active placebo-controlled study
investigating the effects of 25 mg and 5 mg (p.o.) psilocybin versus placebo (100 mg
nicotinamide) in a psychotherapeutic context in 144 patients with TRD from moderate to severe
degree (ICD-10 F32/F33). After giving written informed consent and down-titration of their
monoaminergic medication under supervision of the treating psychiatrist and the study team,
patients will be randomly assigned to one of four trial arms using an online randomization
tool: 1) receiving placebo (100 mg nicotinamide) at the first session and the full dose (25
mg) at the second; 2) receiving the presumably sub-effective dose (5 mg) at the first session
and the full dose (25 mg) at the second; 3a) receiving the full dose (25 mg) at the first
session and 5 mg at the second; 3b) receiving the full dose at both sessions. The two dosing
sessions are accompanied by three preparatory and four integration sessions.
Drug administration must occur under psychotherapeutic conditions. Two trained therapists
(one male, one female) will be assigned to each patient and be present during each dosing,
preparatory and integration sessions. We will follow the safety guidelines provided by
Johnson et al. (2), including a thorough preparation, establishment of trust/rapport, a safe
and pleasing physical environment and sufficient interpersonal support. For safety reasons
and close monitoring, patients will stay hospitalized for one night after each dosing session
(i.e. in-patient setting).
Phase:
Phase 2
Details
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Collaborators:
Charite University, Berlin, Germany German Federal Ministry of Education and Research MIND Foundation gGmbH Usona Institute