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OpenTrials
Active, Not Recruiting

NCT Number: NCT04433858

An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VA Palo Alto Healthcare System/Stanford Medicine, Palo Alto, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of at least moderate Major Depressive Disorder (MDD)

Exclusion criteria

  • Comorbidities

Note for CA site: Only Veterans are Eligible

Treatment and study plan

Psilocybin

Drug

open-label

Other names: COMP360

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: From Baseline (Day -1) to three weeks post-dose.

    MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = >50% decrease and Remission =< 10 actual score.

Sponsors and collaborators

Lead sponsor

Sheppard Pratt Health System

Other

Collaborators

  • COMPASS Pathways

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jun 16, 2020
Registry last updated
Aug 9, 2024

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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