Status:
COMPLETED
The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Lead Sponsor:
Sheppard Pratt Health System
Collaborating Sponsors:
COMPASS Pathways
Conditions:
Treatment Resistant Depression
Suicidal Ideation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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
- 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
- Current or past history of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, etc.
- Current alcohol or substance use disorder
Key Trial Info
Start Date :
March 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05220410
Start Date
March 28 2022
End Date
May 12 2025
Last Update
December 24 2025
Active Locations (1)
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1
Sheppard Pratt Health System
Baltimore, Maryland, United States, 21204