Clinical TrialMajor Depressive Disorder (MDD)PsilocybinPlaceboTerminated

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

Observational long-term follow-up (n=24) of participants from PSIL201 (psilocybin or niacin) using web surveys and telephone interviews over 24 months.

Target Enrollment
24 participants
Study Type
observational
Design
Non-randomized

Detailed Description

Long-term observational cohort follow-up of participants dosed in Study PSIL201; assessments conducted by a central site at months 2–6 (±7 days) and months 8, 10, 12, 14, 16, 18, 20, 22, and 24 (±14 days).

Data collection comprises web surveys and telephone interviews to capture clinical status and patient-reported outcomes; no investigational product is administered in this study.

Study Arms & Interventions

Psilocybin group

experimental

Participants previously dosed with psilocybin in parent Study PSIL201; no new intervention administered in this follow-up.

Interventions

  • Psilocybin
    via Other• observational

    No intervention administered as part of this follow-up; participants previously received psilocybin in Study PSIL201.

Niacin control

inactive

Participants previously dosed with niacin in parent Study PSIL201; no new intervention administered in this follow-up.

Interventions

  • Placebo
    via Other• observational

    No intervention administered as part of this follow-up; participants previously received niacin in Study PSIL201.

Participants

Ages
21 – 65
Sexes
Male & Female

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

Study Details

Locations

Segal Trials — Lauderhill, Florida, United States

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