CompletedPhase 2

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

United States20 participantsStarted 2022-03-28

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Modified Scale for Suicidal Ideation (MSSI)

Timeframe: 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)

Trial details

NCT IDNCT05220410

SponsorSheppard Pratt Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-12

View on ClinicalTrials.gov More Treatment Resistant Depression trials