Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression

The study aims to investigate the safety and efficacy of oral psilocybin administered under supportive conditions in treatment-resistant major depression (TRD).

Status Recruiting
Results Published No
Start date 01 April 2021
End date 01 April 2024
Chance of happening 90%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 144
Sex All
Age 25- 65
Therapy No

Trial Details

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).

NCT Number NCT04670081

Sponsors & Collaborators

Central Institute of Mental Health
This company doesn't have a full profile yet, it is linked to a clinical trial.

MIND Foundation
The MIND Foundation is the European (Germany-based) non-profit that connects psychedelic research and education (mind academy). It is also the organization behind the INSIGHT conference.

Usona Institute
The Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).

German Federal Ministry of Education and Research
The German Federal Ministry of Education and Research has awarded federal funding to a clinical trial with psychedelics, in what is a first for Germany.


Methodological challenges in psychedelic drug trials: Efficacy and safety of psilocybin in treatment-resistant major depression (EPIsoDE) – Rationale and study design
This paper (2022) details the rationale and study design for an upcoming double-blind placebo-controlled trial (n=144) which will assess the safety and efficacy of using psilocybin in a cohort with treatment-resistant depression.

Measures Used

Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale (HDRS) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluating recovery. The scale consists of 17 items which each item being scoring on a 3 or 5 point scale. The higher the score, the more likely a person is depressed.

Post Linked

The Ethical Compass of Minding to Psychotherapy: How Much Support is Necessary?
A battle of Compass Pathways (Guy Goodwin) vs the MIND Foundation (Max Wolff). The need for psychotherapy or just psychological support.

Data attribution

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