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Trial record 1 of 2 for:    PSIL201
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PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT04353921
Recruitment Status : Terminated (Low enrollment and inability to achieve statistical significance)
First Posted : April 21, 2020
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Usona Institute

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Major Depressive Disorder Other: No intervention will be administered as part of this study.

Study Design
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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: A Two-Year Observational Follow-up Study of Subjects With Major Depressive Disorder Following a Randomized, Double-Blind Single-Dose of Psilocybin or Niacin-Control
Actual Study Start Date : June 30, 2020
Actual Primary Completion Date : October 18, 2022
Actual Study Completion Date : October 18, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Niacin

Groups and Cohorts
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Group/Cohort Intervention/treatment
Single-Dose of Psilocybin Other: No intervention will be administered as part of this study.
No intervention will be administered as part of this study.
Niacin-Control Other: No intervention will be administered as part of this study.
No intervention will be administered as part of this study.


Outcome Measures
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Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale [ Time Frame: 6 Months post-dosing in PSIL201 ]
    Between-group difference in mean change from baseline (prior to dosing in PSIL201) in Montgomery-Asberg Depression Rating Scale (MADRS)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Enrollment is constrained to those participants dosed with investigational drug (psilocybin or niacin) in Study PSIL201.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04353921


Locations
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United States, Florida
Segal Trials
Lauderhill, Florida, United States, 33319
Sponsors and Collaborators
Usona Institute
More Information
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Responsible Party: Usona Institute
ClinicalTrials.gov Identifier: NCT04353921    
Other Study ID Numbers: PSIL201-LTFU
First Posted: April 21, 2020    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms