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

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.

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 Pathways
COMPASS 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 study
This 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 Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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