- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433858
An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)
December 16, 2022 updated by: Scott T. Aaronson, M.D, Sheppard Pratt Health System
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Palo Alto, California, United States, 94304
- Stanford Exploratory Therapeutics Laboatory
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Palo Alto, California, United States, 94304
- VA Palo Alto Healthcare System/Stanford Medicine
-
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Maryland
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Baltimore, Maryland, United States, 21204
- Sheppard Pratt Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of at least moderate Major Depressive Disorder (MDD)
Exclusion Criteria:
- Comorbidities
Note for CA sites: Only Veterans are Eligible
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psilocybin
25mg of Psilocybin
|
open-label
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From Baseline (Day -1) to three weeks post-dose.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott Aaronson, MD, Sheppard Pratt Health System
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Anticipated)
October 24, 2023
Study Completion (Anticipated)
October 24, 2023
Study Registration Dates
First Submitted
June 13, 2020
First Submitted That Met QC Criteria
June 13, 2020
First Posted (Actual)
June 16, 2020
Study Record Updates
Last Update Posted (Estimate)
December 20, 2022
Last Update Submitted That Met QC Criteria
December 16, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14947563
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Yale UniversityTerminated
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