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

Last updated: March 17, 2025
Sponsor: Sheppard Pratt Health System
Overall Status: Active - Not Recruiting

Phase

2

Condition

Depression

Suicide

Treatment

Psilocybin

Clinical Study ID

NCT05220410
49348
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 immediateintent

  • Failure to respond to 2 medications in the current episode

Exclusion

Exclusion Criteria:

  • Current or past history of schizophrenia, psychotic disorder, bipolar disorder,borderline personality disorder, etc.

  • Current alcohol or substance use disorder

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Psilocybin
Phase: 2
Study Start date:
March 28, 2022
Estimated Completion Date:
May 13, 2025

Connect with a study center

  • Sheppard Pratt Health System

    Baltimore, Maryland 21204
    United States

    Site Not Available

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