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NCT04353921 · ClinicalTrials.gov registry record
PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder
A clinical trial, sponsored by Usona Institute.
- Terminated
- Registry status
- 26
- Enrollment target
NCT04353921: Clinical Trial study, sponsored by Usona Institute.
NCT04353921 is a clinical trial that was terminated before completion, run by Usona Institute. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04353921 was terminated before completion, sponsored by Usona Institute.
- TERMINATED
- Registry status
- 26 participants
- Enrollment target
Study Summary
This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent were enrolled into this study and completed web surveys and telephone interviews conducted by one central site at the following time intervals: months 3 and 6 (± 7 days for each assessment) and months 10 and 12 (± 14 days for each assessment).
Primary Outcome
Between-group difference in mean change from baseline (prior to dosing in PSIL201) in Montgomery-Asberg Depression Rating Scale (MADRS) to 6 months post-dosing in Study PSIL201
Interventions
- OTHER No intervention will be administered as part of this study.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-06-30 |
| Est. Completion | 2022-10-18 |
Why NCT04353921 stopped before completion
NCT04353921 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 26 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which No intervention will be administered as part of this study. is the first listed.
NCT04353921 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04353921 about?
NCT04353921 is a clinical study titled "PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder". This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent were enrolled into this study and completed web surveys and telephone interviews conducted by one central site at the following time intervals: months 3...
What is the current status of trial NCT04353921?
This trial is currently terminated. The enrollment target is 26 participants. The study started on 2020-06-30. Estimated completion is 2022-10-18.
What interventions are being tested in trial NCT04353921?
The interventions under investigation include: No intervention will be administered as part of this study. (OTHER).
Who is sponsoring clinical trial NCT04353921?
This trial is sponsored by Usona Institute, which has 5 total clinical trials registered on ClinicalTrials.gov.
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