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

• ClinicalTrials.gov Identifier: NCT04353921
• Recruitment Status: Enrolling by invitation
• First Posted: April 21, 2020
• Last Update Posted: September 30, 2021
• Sponsor: Usona Institute
• 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
• 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

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

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