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

Usona Institute

Status: Terminated

Conditions: Major Depressive Disorder

Treatments: Other: No intervention will be administered as part of this study.

Study type: Observational

Funder types: Other

Identifiers

NCT04353921

PSIL201-LTFU

Details and patient eligibility

About

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).

Enrollment: 24 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 2 patient groups

Single-Dose of Psilocybin

Treatment:

Other: No intervention will be administered as part of this study.

Niacin-Control

Treatment:

Other: No intervention will be administered as part of this study.