Low enrollment and inability to achieve statistical significance

This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent were enrolled into this study and completed web surveys and telephone interviews conducted by one central site at the following time intervals: months 3 and 6 (± 7 days for each assessment) and months 10 and 12 (± 14 days for each assessment).

Inclusion Criteria:

• Enrollment and randomization in Study PSIL201
• Ability and willingness to provide informed consent prior to initiation of any study-related procedures

Exclusion Criteria:

• Inability or unwillingness to complete study procedures, including regular completion of web surveys and telephone interviews with study personnel

Enrollment is constrained to those participants dosed with investigational drug (psilocybin or niacin) in Study PSIL201.