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 2022
- 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) Exclusion Criteria:
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)
- Brandon Brown, 410-938-5263, email@example.com
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.