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

Study Overview
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Brief Summary
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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

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

Conditions
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Treatment Resistant Depression, Suicidal Ideation

Intervention / Treatment
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* Drug: Psilocybin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psilocybin<br>25mg of Psilocybin | Drug: Psilocybin<br>* Open-Label<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major depression, Psilocybin, Psychedelic, Treatment resistant depression, Suicidal ideation