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).

Trial Details



Trial Number

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.

Papers

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

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.