Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04353921
Recruitment Status : Enrolling by invitation
First Posted : April 21, 2020
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Usona Institute

Tracking Information
First Submitted Date April 16, 2020
First Posted Date April 21, 2020
Last Update Posted Date September 30, 2021
Actual Study Start Date June 30, 2020
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2020)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder
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
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Enrollment is constrained to those participants dosed with investigational drug (psilocybin or niacin) in Study PSIL201.
Condition Major Depressive Disorder
Intervention Other: No intervention will be administered as part of this study.
No intervention will be administered as part of this study.
Study Groups/Cohorts
  • Single-Dose of Psilocybin
    Intervention: Other: No intervention will be administered as part of this study.
  • Niacin-Control
    Intervention: Other: No intervention will be administered as part of this study.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: September 23, 2021)
100
Original Estimated Enrollment
 (submitted: April 16, 2020)
80
Estimated Study Completion Date May 30, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04353921
Other Study ID Numbers PSIL201-LTFU
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Usona Institute
Original Responsible Party Same as current
Current Study Sponsor Usona Institute
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Usona Institute
Verification Date September 2021