The Safety and Efficacy of Psilocybin in Patients With Treatment-resistant Depression and Chronic Suicidal Ideation
Purpose
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
Conditions
- Treatment Resistant Depression
- Suicidal Ideation
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Psilocybin |
25mg of Psilocybin |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Sheppard Pratt Health System
