- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05675800
Psilocybin for Major Depressive Disorder
April 24, 2023 updated by: Ginger E Nicol, Washington University School of Medicine
Psilocybin for the Treatment of Major Depressive Disorder
The goal of this study is to assess the effectiveness of psilocybin for the treatment of Major Depressive Disorder and potential therapeutic mechanisms.
Enrolled participants will receive a single active dose of psilocybin, or a dose considered high enough to treat depression, administered orally with accompanying psychological support.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
35
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 Contact
- Name: Demetrius Perry
- Phone Number: 314-747-5514
- Email: perry.demetrius@wustl.edu
Study Contact Backup
- Name: Teddi Gray
- Phone Number: 314-747-1862
- Email: grayt@wustl.edu
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
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Currently meeting DSM-V Criteria for a Major Depressive Episode of at least mild-moderate severity
- Aged 18-85
- Ability and willingness to attend study visits and complete study assessments
Exclusion Criteria:
- Presence of medical conditions at screening that may affect the safe administration of psilocybin (including, but not limited to: AST/ALT > 150, QTc > 450ms, MELD > 9)
- Depression deemed secondary to a severe medical condition
- Recent use of any classical psychedelic drug or MDMA
- Recent use of any interventional psychiatric treatment (including: ECT, ketamine, esketamine, TMS)
- Intention to begin any new treatment for depression prior to primary outcome determination
- Use of any excluded medication
- Active substance use disorder
- Presence of any psychiatric condition that may interfere with the safe administration of psilocybin
- Active suicidal ideation
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Psilocybin Active Dose Treatment A
Psilocybin
|
Psilocybin administered with psychological support
|
Experimental: Psilocybin Active Dose Treatment B
Psilocybin
|
Psilocybin administered with psychological support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
Time Frame: 3 weeks post-treatment
|
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
|
3 weeks post-treatment
|
Adverse Events
Time Frame: Up to 12 weeks post-treatment
|
Rates of adverse events related to treatment, as determined by multiple data collection mechanisms
|
Up to 12 weeks post-treatment
|
Study Retention and Completion
Time Frame: Throughout study participation (12-17 weeks)
|
Rates of successful attendance of study visits and completion of study
|
Throughout study participation (12-17 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline
Time Frame: 12 weeks post-treatment
|
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
|
12 weeks post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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 (Anticipated)
January 1, 2024
Primary Completion (Anticipated)
January 1, 2025
Study Completion (Anticipated)
March 31, 2025
Study Registration Dates
First Submitted
November 22, 2022
First Submitted That Met QC Criteria
January 6, 2023
First Posted (Actual)
January 9, 2023
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 24, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202209153
- R25MH112473 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Study protocol and analysis plan will be publicly available on publication of the research.
Individual researchers can request individual participant data collected during the trial, after deidentification, for specifically outlined research-related purposes upon publication.
IPD Sharing Time Frame
Upon publication, indefinitely
IPD Sharing Access Criteria
Investigators with a research plan that is reviewed and approved by the P.I.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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