TerminatedNot Applicable

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

Stopped: Low enrollment and inability to achieve statistical significance

United States26 participantsStarted 2020-06-30

Plain-language 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).

Who can participate

Age range21 Years – 65 Years

SexALL

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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

What they're measuring

Montgomery-Asberg Depression Rating Scale

Timeframe: 6 Months post-dosing in PSIL201

Trial details

NCT IDNCT04353921

SponsorUsona Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-10-18

View on ClinicalTrials.gov More Major Depressive Disorder trials