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.
Compound Psilocybin
Status
Completed
Results Published
Yes
Start date
15 September 2020
End date
14 October 2021
Chance of happening
100%
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.NCT Number NCT04739865
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.
Papers
Psilocybin for treatment resistant depression in patients taking a concomitant SSRI medicationThis 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.