The Safety and Efficacy of Psilocybin in Participants With Treatment Resistant Depression

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression.

Status Completed
Results Published
Start date 01 January 2019
End date 27 September 2021
Chance of happening 100%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 216
Sex All
Age 18- 99
Therapy Yes

Trial Details

The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study

NCT Number NCT03775200

Sponsors & Collaborators

COMPASS Pathways
COMPASS Pathways is a publicly listed company (NASDAQ) that is developing psilocybin for treatment-resistant depression (TRD) for which it has completed a successful Phase IIb trial. COMPASS is one of the largest psychedelic companies and has received substantial investment from atai.


Psilocybin Therapy for Treatment Resistant Depression: Prediction of Clinical Outcome by Natural Language Processing
This article of a language model (NLP, BART) finds that the audio from psychological support sessions (in the COMP360 trial for treatment-resistant depression, n=90 at 12 weeks) can predict clinical outcomes with high (85%) accuracy. The implications of this research signal that audio recordings can be used to predict who will respond to treatment and possibly aid in helping identify who would need more support.

Patient perspectives and experiences with psilocybin treatment for treatment-resistant depression: a qualitative study
This qualitative study (n=11) explores the experiences of treatment-resistant depression (TRD) patients undergoing a double-blind, randomized clinical trial with a single session of oral psilocybin treatment (1, 10, or 25 mg). Three major themes emerged: trust-building and expectation management challenges, navigating the experience, and the need for a more comprehensive treatment. Subthemes included distrust in mental healthcare, managing expectations, profound experiences during the session, and a desire for multiple psilocybin sessions. Insights from patients' perspectives suggest strategies for optimizing psilocybin treatment for TRD, such as individualized preparation, trust-building, additional sessions, and personalized therapy approaches.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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