An Open Label Study of the Safety and Efficacy of Psilocybin in Participants With Treatment-Resistant Depression (P-TRD)

Overview

The primary objective of this study is to evaluate the efficacy of psilocybin (25 mg) administered under supportive conditions to adult participants with severe TRD, in improving depressive symptoms.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2021

Interventions

  • Drug: Psilocybin
    • open-label

Arms, Groups and Cohorts

  • Experimental: Psilocybin
    • 25mg of Psilocybin

Clinical Trial Outcome Measures

Primary Measures

  • Montgomery Asberg Depression Rating Scale (MADRS)
    • Time Frame: From Baseline (Day -1) to three weeks post-dose.
    • MADRS is a clinician-rated scale measuring depression severity, consisting of 10 items, each scored from 0 (normal) to 6 (severe), for a total possible score of 60; higher scores denote greater severity. Response = >50% decrease and Remission =< 10 actual score.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of at least moderate Major Depressive Disorder (MDD)

Exclusion Criteria

  • Comorbidities

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sheppard Pratt Health System
  • Collaborator
    • COMPASS Pathways
  • Provider of Information About this Clinical Study
    • Principal Investigator: Scott T. Aaronson, M.D, Director, Clinical Research Programs – Sheppard Pratt Health System
  • Overall Official(s)
    • Scott Aaronson, MD, Principal Investigator, Sheppard Pratt Health System
  • Overall Contact(s)
    • Kelsie Kaier, 410-938-3126, kkaier@sheppardpratt.org

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