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

This observational cohort study (n=0, terminated) was conducted by the Usona Institute. The study aimed to observe participants from Study PSIL201 who received either psilocybin or niacin for the treatment of Major Depressive Disorder (MDD).

The study involved participants who received the investigational drug in Study PSIL201. They were enrolled in this follow-up study and underwent web surveys and telephone interviews conducted by a central site at specified intervals over two years. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS) to assess the between-group difference in mean change from baseline in MADRS score at 6 months post-dosing in Study PSIL201.

The study, which started on June 30, 2020, was completed on October 18, 2022. However, it was terminated due to low enrollment and the inability to achieve statistical significance. Participation was constrained to those aged 21 to 65 who had received the investigational drug in Study PSIL201. The study location was Lauderhill, Florida, United States.

Topic Depression
Compound Psilocybin
Country United States of America
Visit trial
Status Terminated
Results Published No
Start date 30 June 2020
End date 18 October 2022
Phase Not Applicable
Design Blinded
Type Observational
Generation Second
Participants 24
Sex All
Age 21- 65
Therapy No

Trial Details

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).

NCT Number NCT04353921

Sponsors & Collaborators

Usona Institute
The Usona Institute was founded by Bill Linton and Malynn Utzinger. Currently, 18 people are associated with it. The institute is a non-profit that sponsors psilocybin research (and is funded by sponsors/philanthropists).

Data attribution

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