The Safety and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder

The safety and tolerability of COMP360 in participants with post-traumatic stress disorder (PTSD).

Topic PTSD
Compound Psilocybin
Country United Kingdom
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Trial Details



Trial Number

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.

King's College London
The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London is one of Europe's top centres for mental health and related neurosciences research.

Papers

Investigating the safety and tolerability of single-dose psilocybin for post-traumatic stress disorder: A nonrandomized open-label clinical trial
This Phase II, nonrandomized open-label trial (n=22) tested a single 25 mg dose of psilocybin with psychological support in adults with PTSD. It found the treatment to be safe and well-tolerated, with common side effects such as headache, nausea, crying, and fatigue resolving quickly. Clinically meaningful reductions in PTSD symptoms were observed at weeks 4 and 12, alongside improvements in functioning and quality of life.

Measures Used

Clinician-Administered PTSD Scale for DSM-5
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is often considered the gold standard in PTSD assessment. The 30-item structured interview was developed by staff at the U.S. Department of Veterans Affairs National Centre for PTSD. CAPS can be used to make a current diagnosis, lifetime diagnosis or assess PTSD symptoms over the past week in accordance with DSM-5 criteria.

Data attribution

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