NCT04353921

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 30, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2022

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

April 16, 2020

Last Update Submit

April 27, 2026

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • 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

    6 Months post-dosing in PSIL201

Study Arms (2)

Single-Dose of Psilocybin

Participants randomized to a single oral dose of psilocybin 25 mg in Study PSIL201.

Other: No intervention will be administered as part of this study.

Niacin-Control

Participants randomized to a single oral dose of niacin 100 mg (active comparator) in Study PSIL201.

Other: No intervention will be administered as part of this study.

Interventions

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

No intervention will be administered as part of this study.

Niacin-ControlSingle-Dose of Psilocybin

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Enrollment is constrained to those participants dosed with investigational drug (psilocybin or niacin) in Study PSIL201.

You may qualify if:

  • Enrollment and randomization in Study PSIL201
  • Ability and willingness to provide informed consent prior to initiation of any study-related procedures

You may not qualify if:

  • Inability or unwillingness to complete study procedures, including regular completion of web surveys and telephone interviews with study personnel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innovative Clinical Research, Inc. (formerly Segal Trials)

Lauderhill, Florida, 33319, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Charles Raison, MD

    Usona Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 21, 2020

Study Start

June 30, 2020

Primary Completion

October 18, 2022

Study Completion

October 18, 2022

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

US(1)