PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder
Terminated
- Conditions
- Major Depressive Disorder
- Interventions
- Other: No intervention will be administered as part of this study.
- Registration Number
- NCT04353921
- Lead Sponsor
- Usona Institute
- Brief Summary
This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent will be enrolled into this study and will complete web surveys and telephone interviews conducted by one central site at the following time intervals: months 2, 3, 4, 5 and 6 (± 7 days for each assessment) and months 8, 10, 12, 14, 16, 18, 20, 22 and 24 (± 14 days for each assessment).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Enrollment and intervention with the investigational drug in Study PSIL201
Exclusion Criteria
- Inability or unwillingness to complete study procedures, including regular completion of web surveys and telephone interviews with study personnel
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single-Dose of Psilocybin No intervention will be administered as part of this study. - Niacin-Control No intervention will be administered as part of this study. -
- Primary Outcome Measures
Name Time Method Montgomery-Asberg Depression Rating Scale 6 Months post-dosing in PSIL201 Between-group difference in mean change from baseline (prior to dosing in PSIL201) in Montgomery-Asberg Depression Rating Scale (MADRS)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Segal Trials
🇺🇸Lauderhill, Florida, United States