The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression.
Compound Placebo
Psilocybin
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 studyNCT Number NCT03775200
Sponsors & Collaborators
COMPASS PathwaysCOMPASS 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.
Papers
Psilocybin Therapy for Treatment Resistant Depression: Prediction of Clinical Outcome by Natural Language ProcessingThis 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 ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.