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

Phase 2

Active, not recruiting

• Conditions: Treatment Resistant Depression; Suicidal Ideation
• Interventions: Drug: Psilocybin

• Registration Number: NCT05220410
• Lead Sponsor: Sheppard Pratt Health System

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-21
• Study First Submitted QC: 2022-01-21
• Study First Posted: 2022-02-02
• Study Start: 2022-03-28
• Status Verified: 2024-11
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2025-05-13
• Study Completion: 2025-05-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Psilocybin	Psilocybin	25mg of Psilocybin

Primary Outcome Measures

Name	Time	Method
Columbia-Suicide Severity Rating Scale (C-SSRS)	All Visits - Baseline (Day -1 [V2]) to Week 12 (V10)	The C-SSRS is a semi-structured interview designed to assess the severity and intensity of suicidal ideation, suicidal behavior, and non-suicidal self injurious behavior over a specified time period. The measurement of suicidal ideation is based on five "yes" or "no" questions with accompanying descriptions arranged in order of increasing severity.

Secondary Outcome Measures

Name	Time	Method
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)	The MADRS is a clinician rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity.
Clinical Global Impression - Modified for Depression (CGI-D)	Baseline (V2) to Week 3 (V7) and Week 12 (V10)	The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)	Baseline (V2) to Week 3 (V7), and Week 12 (V10)	The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.
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)	The CHRT-SR is a 12-item self-report measure that systematically assesses both suicidal thinking and associated thoughts that might indicate the propensity for suicidal acts.

Trial Locations

Locations (1)

Sheppard Pratt Health System; 🇺🇸 Baltimore, Maryland, United States