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.
Compound Psilocybin
Country United States of America
Visit trial
Status
Recruiting
Results Published
Start date
01 March 2021
End date
01 January 2022
Phase
Phase II
Design
Open
Type
Interventional
Generation
First
Participants
15
Sex
All
Age
18- 65
Therapy
Yes
Trial Details
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.Trial Number NCT04433858
Sponsors & Collaborators
COMPASS PathwaysCOMPASS Pathways is a publicly listed company (NASDAQ) that is developing psilocybin for treatment-resistant depression (TRD) for which it has completed a successful Phase IIb trial. COMPASS is one of the largest psychedelic companies and has received substantial investment from atai.
Sheppard Pratt Health System
This company doesn't have a full profile yet, it is linked to a clinical trial.
Papers
Single-dose psilocybin for U.S. military Veterans with severe treatment-resistant depression - A first-in-kind open-label pilot studyThis open-label trial (n=15) evaluates the efficacy and safety of psilocybin (25mg) in veterans with severe treatment-resistant depression (TRD). It finds that 60% of participants met response criteria and 53% met remission criteria at 3 weeks post-treatment, with 47% maintaining response and 40% maintaining remission at 12 weeks.
Single-Dose Psilocybin for Depression With Severe Treatment Resistance: An Open-Label Trial
This open-label trial (n=12) conducted at Sheppard Pratt Hospital finds that psilocybin (25mg) significantly decreases depressive symptoms in patients with severe treatment-resistant depression (TRD) at 3 weeks (MADRS −15.8) and 12 weeks (MADRS −17.2) post-treatment. Exploratory analyses suggest the Oceanic Boundlessness dimension correlates with antidepressant responses, while patients with comorbid PTSD show reduced antidepressant effects.
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.