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

Phase 2

Completed

• Conditions: Treatment Resistant Depression
• Interventions: Drug: Psilocybin

• Registration Number: NCT03775200
• Lead Sponsor: COMPASS Pathways

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Study Start: 2019-03-01
• Primary Completion: 2021-07-30
• Study Completion: 2021-09-27
• Results First Submitted: 2023-02-07
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Results First Posted: 2023-04-24
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

Inclusion Criteria

• Diagnosis of TRD

Exclusion Criteria

• Other comorbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	Psilocybin	High dose Psilocybin
Low dose	Psilocybin	Low dose Psilocybin
Medium dose	Psilocybin	Medium dose Psilocybin

Primary Outcome Measures

Name	Time	Method
MADRS Change From Baseline to Week 3, Sensitivity Analysis	Change from Baseline to Week 3	MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score.
Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3	Change from Baseline to Week 3	MADRS is a clinician-rated scale measuring depression symptom severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of between 0 to 60; higher scores denote greater severity. Response \>= 50% decrease and remission \<= 10 total score.

Trial Locations

Locations (25)

Kadima Neuropsychiatry Institute; 🇺🇸 La Jolla, California, United States

Altman Clinical and Translational Research Institute, University of California; 🇺🇸 San Diego, California, United States

Stanford Department of Psychiatry; 🇺🇸 Stanford, California, United States

Mood and Anxiety Disorders Program Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Ray Worthy Psychiatry LLC; 🇺🇸 New Orleans, Louisiana, United States

Sheppard Pratt Health System; 🇺🇸 Baltimore, Maryland, United States

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States

UT Center of Excellence on Mood Disorders, University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States

Canadian Rapid Treatment Centre of Excellence; 🇨🇦 Mississauga, Ontario, Canada

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada

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