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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220410
• Other study ID #: 49348
• Status: Recruiting
• Phase: Phase 2
• Start date: March 28, 2022
• Est. completion date: April 2024

Study information

• Verified date: February 2024
• Source: Sheppard Pratt Health System
• Contact: Audrey Shoultz
• Phone: 4109385263
• Email: audrey.shoultz[@]sheppardpratt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Suicidal Ideation
• Treatment Resistant Depression

Intervention

Drug:
• Psilocybin
Open-Label

Locations

Country	Name	City	State
United States	Sheppard Pratt Health System	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sheppard Pratt Health System	COMPASS Pathways

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	Columbia-Suicide Severity Rating Scale (C-SSRS)	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.	All Visits - Baseline (Day -1 [V2]) to Week 12 (V10)
Secondary	Montgomery-Åsberg Depression Rating Scale (MADRS)	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.	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	Clinical Global Impression - Modified for Depression (CGI-D)	The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.	Baseline (V2) to Week 3 (V7) and Week 12 (V10)
Secondary	Clinical Global Impressions - Modified for Suicidal Ideation (CGI-SI)	The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.	Baseline (V2) to Week 3 (V7), and Week 12 (V10)
Secondary	Concise Health Risk Tracking Self Report 12 Items (CHRT-SR)	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.	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)