Evaluation of Psilocybin-Assisted Psychotherapy in Treating Severe Depression in Patients With PTSD
This randomized, double-blind, placebo-controlled study (n=160) aims to evaluate the safety, tolerability, and efficacy of Psilocybin-Assisted Psychotherapy (APEX-002-A02) in treating severe depression among adults with Post-Traumatic Stress Disorder (PTSD).
Details
Randomized, quadruple-blind, parallel-group trial (n=160) comparing a single active psilocybin formulation (APEX-002-A02) versus matched placebo, administered with psychotherapeutic support to adults with PTSD and severe depression.
Rationale: psilocybin has demonstrated preliminary efficacy and an acceptable safety profile for depressive symptoms across prior studies; this trial evaluates its effect on severe depression in the context of chronic PTSD.
Key eligibility: adults 18–65 with DSM-5 PTSD ≥6 months, CAPS-5 ≥35, and BDI-II ≥30; exclusions include psychosis/bipolar history, first-degree relatives with schizophrenia/bipolar, unstable medical illness, and recent suicidal behaviour per C-SSRS.