PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder

Terminated

• Conditions: Major Depressive Disorder

• 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

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Study Start: 2020-06-30
• Primary Completion: 2022-10-18
• Study Completion: 2022-10-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-29
• Last Update Posted: 2022-12-02

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

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)

Trial Locations

Locations (1)

Segal Trials; 🇺🇸 Lauderhill, Florida, United States