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TerminatedN/A

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

NCT04353921 · Usona Institute

Closed to entry
Status
Not accepting participants
Not applicable
Phase
26
Target enrolment
1
Study sites
1 US states

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Montgomery-Asberg Depression Rating Scale

    Measured over 6 Months post-dosing in PSIL201

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 65 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Enrollment and randomization in Study PSIL201 * Ability and willingness to provide informed consent prior to initiation of any study-related procedures Exclusion Criteria: * Inability or unwillingness to complete study procedures, including regular completion of web surveys and telephone interviews with study personnel

Where

1 study site

FacilityCityRegionCountry
Innovative Clinical Research, Inc. (formerly Segal Trials)LauderhillFloridaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04353921 on ClinicalTrials.gov →

Last updated in the registry 2026-05-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

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