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NCT04353921 Clinical Trial

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

Major Depressive Disorder Clinical Trial

Official title:
A Two-Year Observational Follow-up Study of Subjects With Major Depressive Disorder Following a Randomized, Double-Blind Single-Dose of Psilocybin or Niacin-Control

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04353921
Other study ID # PSIL201-LTFU
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 30, 2020
Est. completion date October 18, 2022

Study information
Verified date November 2022
Source Usona Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 24
Est. completion date October 18, 2022
Est. primary completion date October 18, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• No intervention will be administered as part of this study.
No intervention will be administered as part of this study.

Locations
Country Name City State
United States Segal Trials Lauderhill Florida

Sponsors (1)
Lead Sponsor Collaborator
Usona Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Montgomery-Asberg Depression Rating Scale Between-group difference in mean change from baseline (prior to dosing in PSIL201) in Montgomery-Asberg Depression Rating Scale (MADRS) 6 Months post-dosing in PSIL201
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