Trial | NCT03775200  Report issue

Official Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Study Participants

    233
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression
The Safety and Efficacy of Psilocybin in Participants with Treatment Resistant Depression - a dose-ranging study
Study Started
Mar 01
2019
Primary Completion
Jul 30
2021
Study Completion
Sep 27
2021
Results Posted
Apr 24
2023
Last Update
Apr 24
2023

Drug Psilocybin

Dose-finding

Low dose Experimental

Low dose Psilocybin

Medium dose Experimental

Medium dose Psilocybin

High dose Experimental

High dose Psilocybin

Criteria 

Inclusion Criteria:

Diagnosis of TRD

Exclusion Criteria:

Other comorbidities

Summary

25 mg COMP360 Psilocybin

10 mg COMP360 Psilocybin

1 mg COMP360 Psilocybin

All Events

Event Type Organ System Event Term 25 mg COMP360 Psilocybin 10 mg COMP360 Psilocybin 1 mg COMP360 Psilocybin

Montgomery Asberg Depression Rating Scale (MADRS) 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.

25 mg COMP360 Psilocybin

-12.0
units on a scale (Mean)
Standard Deviation: 12.98

10 mg COMP360 Psilocybin

-8.9
units on a scale (Mean)
Standard Deviation: 10.94

1 mg COMP360 Psilocybin

-6.8
units on a scale (Mean)
Standard Deviation: 11.10

MADRS Change From Baseline to Week 3, Sensitivity Analysis

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.

25 mg COMP360 Psilocybin

-12.0
units on a scale (Mean)
Standard Deviation: 12.98

10 mg COMP360 Psilocybin

-8.9
units on a scale (Mean)
Standard Deviation: 11.11

1 mg COMP360 Psilocybin

-6.7
units on a scale (Mean)
Standard Deviation: 11.18

Total

233
Participants

Age, Continuous

39.8
years (Mean)
Standard Deviation: 12.19

Age, Categorical

Race (NIH/OMB)

Region of Enrollment

Sex: Female, Male

Overall Study

25 mg COMP360 Psilocybin

10 mg COMP360 Psilocybin

1 mg COMP360 Psilocybin