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

Treatment Resistant Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04433858
• Other study ID #: 14947563
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 1, 2021
• Est. completion date: October 24, 2023

Study information

• Verified date: December 2022
• Source: Sheppard Pratt Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: October 24, 2023
• Est. primary completion date: October 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Comorbidities

Note for CA sites: Only Veterans are Eligible

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Drug:
• Psilocybin
open-label

Locations

Country	Name	City	State
United States	Sheppard Pratt Health System	Baltimore	Maryland
United States	Stanford Exploratory Therapeutics Laboatory	Palo Alto	California
United States	VA Palo Alto Healthcare System/Stanford Medicine	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Sheppard Pratt Health System	COMPASS Pathways

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale (MADRS)	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.	From Baseline (Day -1) to three weeks post-dose.