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NCT03866174 · ClinicalTrials.gov registry record · Phase 2
A Study of Psilocybin for Major Depressive Disorder (MDD)
A Phase 2 study, sponsored by Usona Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 347
- Enrollment target
NCT03866174 is a Phase 2 study that has completed, run by Usona Institute. The registered enrollment target is 347 participants.
The verdict
NCT03866174, a Phase 2 study, has completed, sponsored by Usona Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 347 participants
- Enrollment target
Study Summary
One hundred participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of psilocybin or a single 100 mg oral dose of niacin. Niacin will serve as an active placebo. The purpose of this study is to evaluate the potential efficacy of a single 25 mg oral dose of psilocybin for MDD compared to the active placebo in otherwise medically-healthy participants, assessed as the difference between groups in changes in depressive symptoms from Baseline to Day 43 post-dose.
Interventions
- DRUG Niacin
- DRUG Psilocybin
- OTHER Set and Setting (SaS) Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2020-01-23 |
| Est. Completion | 2022-06-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03866174
The ClinicalTrials.gov registry entry for NCT03866174 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 347 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Usona Institute, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Niacin is the first listed.
NCT03866174 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03866174 about?
NCT03866174 is a clinical study titled "A Study of Psilocybin for Major Depressive Disorder (MDD)". One hundred participants, ages 21 to 65, who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for major depressive disorder (MDD) will be stratified by study site and randomized with a 1-to-1 allocation under double-blind conditions to receive a single 25 mg oral dose of p...
What is the current status of trial NCT03866174?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 347 participants. The study started on 2020-01-23. Estimated completion is 2022-06-28.
What interventions are being tested in trial NCT03866174?
The interventions under investigation include: Niacin (DRUG), Psilocybin (DRUG), Set and Setting (SaS) Protocol (OTHER).
Who is sponsoring clinical trial NCT03866174?
This trial is sponsored by Usona Institute, which has 5 total clinical trials registered on ClinicalTrials.gov.
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