An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Sponsor
Sheppard Pratt Health System (Other)
Overall Status
Recruiting
CT.gov ID
NCT04433858
Collaborator
COMPASS Pathways (Industry)
15
3
1
13
5
0.4
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
Actual Study Start Date
:
Mar 1, 2021
Anticipated Primary Completion Date
:
Apr 1, 2022
Anticipated Study Completion Date
:
Apr 1, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Psilocybin 25mg of Psilocybin |
Drug: Psilocybin
open-label
|
Outcome Measures
Primary Outcome Measures
- Montgomery Asberg Depression Rating Scale (MADRS) [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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Diagnosis of at least moderate Major Depressive Disorder (MDD)
Exclusion Criteria:
- Comorbidities
Note for CA sites: Only Veterans are Eligible
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford Exploratory Therapeutics Laboatory | Palo Alto | California | United States | 94304 |
| 2 | VA Palo Alto Healthcare System/Stanford Medicine | Palo Alto | California | United States | 94304 |
| 3 | Sheppard Pratt Health System | Baltimore | Maryland | United States | 21204 |
Sponsors and Collaborators
- Sheppard Pratt Health System
- COMPASS Pathways
Investigators
- Principal Investigator: Scott Aaronson, MD, Sheppard Pratt Health System
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Scott T. Aaronson, M.D,
Director, Clinical Research Programs,
Sheppard Pratt Health System
ClinicalTrials.gov Identifier:
NCT04433858
Other Study ID Numbers:
- 14947563
First Posted:
Jun 16, 2020
Last Update Posted:
Dec 21, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: