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CompletedPhase 2

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

NCT05220410 · Sheppard Pratt Health System

Closed to entry
Status
Not accepting participants
Phase 2
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Modified Scale for Suicidal Ideation (MSSI)

    Measured over 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)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years
Ages
All
Sex
Not accepted
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

Where

1 study site

FacilityCityRegionCountry
Sheppard Pratt Health SystemBaltimoreMarylandUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05220410 on ClinicalTrials.gov →

Last updated in the registry 2025-12-24. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits