Psilocybin for Major Depressive Disorder

Sponsor

Washington University School of Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05675800

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Arms

26.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Psilocybin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

35 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Psilocybin for the Treatment of Major Depressive Disorder

Anticipated Study Start Date :

Jan 13, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psilocybin Active Dose Treatment A Psilocybin	Drug: Psilocybin Psilocybin administered with psychological support
Experimental: Psilocybin Active Dose Treatment B Psilocybin	Drug: Psilocybin Psilocybin administered with psychological support

Arm

Intervention/Treatment

Experimental: Psilocybin Active Dose Treatment A

Psilocybin

Drug: Psilocybin

Psilocybin administered with psychological support

Experimental: Psilocybin Active Dose Treatment B

Psilocybin

Drug: Psilocybin

Psilocybin administered with psychological support

Outcome Measures

Primary Outcome Measures

MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline [3 weeks post-treatment]
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms
Adverse Events [Up to 12 weeks post-treatment]
Rates of adverse events related to treatment, as determined by multiple data collection mechanisms
Study Retention and Completion [Throughout study participation (12-17 weeks)]
Rates of successful attendance of study visits and completion of study

Secondary Outcome Measures

MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline [12 weeks post-treatment]
Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Washington University School of Medicine
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Ginger Nicol, MD, Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ginger E Nicol, Associate Professor of Psychiatry, Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT05675800

Other Study ID Numbers:

202209153
R25MH112473

First Posted:

Jan 9, 2023

Last Update Posted:

Jan 9, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depressive Disorder

Depression

Depressive Disorder, Major

Psilocybin

Study Results

No Results Posted as of Jan 9, 2023