A Phase 2 interventional study of Psilocybin in Treatment Resistant Depression, sponsored by Sheppard Pratt Health System. Active, not recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Sheppard Pratt Health System · Phase 2, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 27 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Sheppard Pratt Health System is the lead sponsor of 14 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Note for CA site: Only Veterans are Eligible
25mg of Psilocybin Note: CA site only is re-dosing participants with an exacerbation in depressive symptoms at a minimum of 12 months post-initial dosing.
Drug: Psilocybin
open-label
Also known as: COMP360
Montgomery Asberg Depression Rating Scale (MADRS)
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.
Time frame: From Baseline (Day -1) to three weeks post-dose.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Sheppard Pratt Health System