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

Usona Institute26 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Major Depressive Disorder

Interventions

No intervention will be administered as part of this study.OTHER

No intervention will be administered as part of this study.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Innovative Clinical Research, Inc. (formerly Segal Trials)

Lauderhill, Florida, United States

Outcomes

Primary Outcomes

Montgomery-Asberg Depression Rating Scale

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

Time frame: 6 Months post-dosing in PSIL201

Data from ClinicalTrials.gov

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