The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression

This open-label, interventional trial (n=19) explored the effectiveness of 25mg of psilocybin as adjunctive therapy to SSRI use in participants with treatment-resistant depression (TRD).

A previous study demonstrated a significant decrease in depressive symptoms after treatment with psilocybin and psychological support, with over 40% of participants maintaining their response at 3 months.

Topic Treatment-Resistant Depression Depression
Compound Psilocybin
Country United States of America Ireland
Visit trial
Status Completed
Results Published Yes
Start date 15 September 2020
End date 14 October 2021
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 20
Sex All
Age 18- 99
Therapy Yes

Trial Details

A recent open label study of the effects of psilocybin in participants with treatment-resistant depression (TRD) showed rapid significant decrease of depressive symptoms after treatment with psilocybin coupled with psychological support. Over 40% of participants sustained response at 3 months. In this study, the aim is to explore effectiveness of 25 mg of psilocybin as an adjunctive therapy in participants with TRD.

Trial Number NCT04739865

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.

Papers

Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medication
This open-label Phase II trial (n=19) investigates the safety, tolerability, and efficacy of synthetic psilocybin (COMP360) as an adjunct to selective serotonin reuptake inhibitors (SSRIs) in adults with treatment-resistant depression (TRD). The study found no serious treatment-emergent adverse events or increased suicidal ideation. It reported a significant decrease in depression (MADRS) and Clinical Global Impression–Severity (CGI-S) scores at week 3, with response and remission observed in 42.1% of participants.

Data attribution

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