Psilocybin for Major Depressive Disorder

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• Status: Withdrawn
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Psilocybin

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Ginger Nicol, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): 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): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Psychotropic Drugs; Hallucinogens; Psilocybin
• 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