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

Sponsor

Sheppard Pratt Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT05220410

Collaborator

COMPASS Pathways (Industry)

Enrollment

Location

Arm

22.9

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Treatment Resistant Depression Suicidal Ideation	Drug: Psilocybin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 4, 2022

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Psilocybin 25mg of Psilocybin	Drug: Psilocybin Open-Label

Arm

Intervention/Treatment

Experimental: Psilocybin

25mg of Psilocybin

Drug: Psilocybin

Open-Label

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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