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

NCT ID: NCT04353921

Last Updated: 2022-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2022-10-18

Brief Summary

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This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent will be enrolled into this study and will complete web surveys and telephone interviews conducted by one central site at the following time intervals: months 2, 3, 4, 5 and 6 (± 7 days for each assessment) and months 8, 10, 12, 14, 16, 18, 20, 22 and 24 (± 14 days for each assessment).

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Single-Dose of Psilocybin

No intervention will be administered as part of this study.

Intervention Type OTHER

No intervention will be administered as part of this study.

Niacin-Control

No intervention will be administered as part of this study.

Intervention Type OTHER

No intervention will be administered as part of this study.

Interventions

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No intervention will be administered as part of this study.

No intervention will be administered as part of this study.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Enrollment and intervention with the investigational drug in Study PSIL201

Exclusion Criteria

* Inability or unwillingness to complete study procedures, including regular completion of web surveys and telephone interviews with study personnel
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Usona Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Segal Trials

Lauderhill, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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PSIL201-LTFU

Identifier Type: -

Identifier Source: org_study_id

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