Open-label, single-group Phase II study (n=27 actual) assessing a single 25 mg oral psilocybin dose under supportive conditions for adults with treatment-resistant depression.
Open-label single-group Phase II trial administering 25 mg oral psilocybin (COMP360) to adults with treatment-resistant depression under supportive therapeutic conditions; primary purpose is treatment.
Actual enrolment reported as 27. CA site includes a re-dosing option for participants with symptom exacerbation at least 12 months after initial dosing; outcomes include depressive symptom change and safety/tolerability measures.
Single-group open-label 25 mg psilocybin; CA site may re-dose participants with symptom exacerbation ≥12 months after initial dosing.
COMP360 (psilocybin); open-label
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.