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: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: January 2021
- Drug: Psilocybin
Arms, Groups and Cohorts
- Experimental: Psilocybin
- 25mg of Psilocybin
Clinical Trial Outcome 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
- Diagnosis of at least moderate Major Depressive Disorder (MDD)
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Sheppard Pratt Health System
- 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, email@example.com
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