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

Psilocybin

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).

Intervention / Treatment

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

Condition or Disease

Major Depressive Disorder

Phase

Study Design

Study type:	OBSERVATIONAL
Status:	Terminated
Study results:	No Results Available
Age:	21 Years to 65 Years
Enrollment:	24 (ACTUAL)
Funded by:	Other
Time Perspective:	Other
Observational Model:	Cohort
Masking

Clinical Trial Dates

Start date:	Jun 30, 2020	ACTUAL
Primary Completion:	Oct 18, 2022	ACTUAL
Completion Date:	Oct 18, 2022	ACTUAL
Study First Posted:	Apr 21, 2020	ACTUAL
Results First Posted:	Aug 30, 2020
Last Updated:	Nov 29, 2022

Sponsors / Collaborators

Lead Sponsor: Usona Institute

Lead sponsor is responsible party

Responsible Party: N/A

Location

Lauderhill, Florida, USA

Participant Groups

No description provided
No description provided

Eligibility Criteria

Sex:	All
Minimum Age:	21
Maximum Age:	65
Age Groups:	Adult / Older Adult
Healthy Volunteers:	Yes

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

Primary Outcomes

Between-group difference in mean change from baseline (prior to dosing in PSIL201) in Montgomery-Asberg Depression Rating Scale (MADRS)

More Details

NCT Number:	NCT04353921
Other IDs:	PSIL201-LTFU
Study URL:	https://clinicaltrials.gov/study/NCT04353921

Last updated: Sep 29, 2023