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

Phase 2CompletedNCT05220410

Sheppard Pratt Health System20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Treatment Resistant Depression Suicidal Ideation

Interventions

PsilocybinDRUG

Open-Label

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Sheppard Pratt Health System

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

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.

Time frame: 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)

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.

Time frame: 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)

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.

Time frame: 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)

The CGI is a 3-item observer-rated scale that measures illness severity, global improvement or change and therapeutic response.

Data from ClinicalTrials.gov

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