The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation

NCT05220410 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 49348
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore the safety and tolerability of a single dose of psilocybin (25mg) administered under supportive conditions to adult participants with TRD and chronic suicidal ideation

Conditions

Treatment Resistant Depression; Suicidal Ideation

Keywords

Psilocybin; Psychedelic; Major depression; Treatment resistant depression; Suicidal ideation

Outcome Measures

Primary Outcomes (1)

• Modified Scale for Suicidal Ideation (MSSI)

  The MSSI is an 18-item clinician rated scale to assess the presence or absence of suicide ideation and the degree of severity of suicidal ideas. Each of the 18 items is rated on a scale of 0 to 3 where a higher score indicates greater suicidal severity.

  Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)

Secondary Outcomes (5)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9), and Week 12 (V10)

• Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)

  Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), Week 6 (V8), Week 9 (V9) and Week 12 (V10)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline (V2) to Day 1 (V4), Week 1 (V5), Week 2 (V6), Week 3 (V7), and Week 12 (V10)

• Clinical Global Impression - Modified for Depression (CGI-D)

  Baseline (V2) to Week 3 (V7) and Week 12 (V10)

• Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)

  Baseline (V2) to Week 3 (V7), and Week 12 (V10)

Study Arms (1)

Psilocybin

EXPERIMENTAL

25mg of Psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

Open-Label

Psilocybin

Eligibility Criteria

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

You may qualify if:

• Between 18 and 65 years of age at Screening
• Diagnosis of Major Depressive Disorder (MDD)
• Significant level of suicidal thoughts with active ideation and without immediate intent
• Failure to respond to 2 medications in the current episode

You may not qualify if:

• Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc.
• Current alcohol or substance use disorder

Sponsors & Collaborators

• Sheppard Pratt Health System: lead
• COMPASS Pathways: collaborator

Study Sites (1)

Sheppard Pratt Health System

Baltimore, Maryland, 21204, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Suicidal Ideation; Depressive Disorder, Major

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Scott Aaronson, MD

  Sheppard Pratt Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research Programs

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 2, 2022
• Study Start: March 28, 2022
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)