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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sheppard Pratt Health System
• Collaborator: COMPASS Pathways
• Treatments: Psilocybin

Criteria

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