Psilocybin for Major Depressive Disorder

NCT05675800 | Withdrawn Phase 2 FDA Drug

• 2 other identifiers: 202209153R25MH112473
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline

  Depression severity rating scale, range 0-60 with higher scores indicating more severe symptoms

  3 weeks post-treatment

• Adverse Events

  Rates of adverse events related to treatment, as determined by multiple data collection mechanisms

  Up to 12 weeks post-treatment

• Study Retention and Completion

  Rates of successful attendance of study visits and completion of study

  Throughout study participation (12-17 weeks)

Secondary Outcomes (1)

• MADRS (Montgomery-Asberg Depression Rating Scale) Change from Baseline

  12 weeks post-treatment

Study Arms (2)

Psilocybin Active Dose Treatment A

EXPERIMENTAL

Psilocybin

Drug: Psilocybin

Psilocybin Active Dose Treatment B

EXPERIMENTAL

Psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

Psilocybin administered with psychological support

Psilocybin Active Dose Treatment A; Psilocybin Active Dose Treatment B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Ginger Nicol, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: January 9, 2023
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 31, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication, indefinitely
• Access Criteria: Investigators with a research plan that is reviewed and approved by the P.I.