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Completed

NCT Number: NCT03775200

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

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

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Canadian Rapid Treatment Centre of Excellence, Mississauga, Ontario, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of TRD

Exclusion criteria

  • Other comorbidities

Treatment and study plan

Psilocybin

Drug

Dose-finding

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale (MADRS) Change From Baseline to Week 3

    Time frame: 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.

  2. MADRS Change From Baseline to Week 3, Sensitivity Analysis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

COMPASS Pathways

Industry

Registry information

Acronym: P-TRD

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2018
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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