A Phase 3 Trial to Assess CYB003 in Major Depressive Disorder (EMBRACE)
Phase III, quadruple-blind, randomised, placebo-controlled trial (n=330) of CYB003 (8 mg and 16 mg; two dosing sessions ~3 weeks apart) as adjunctive treatment for major depressive disorder.
Details
Randomised, parallel-group, quadruple-masked Phase III study evaluating two dose levels of CYB003 versus matching placebo as adjunctive therapy in adults with major depressive disorder on a stable antidepressant regimen.
Participants receive two medicine sessions approximately three weeks apart (8 mg or 16 mg CYB003 or placebo) with manualized psychological support provided throughout; primary outcomes assess efficacy, safety and tolerability.
Key safety exclusions include psychotic disorders, first-degree family history of schizophrenia/schizoaffective disorder/bipolar I, significant suicide risk within 12 months, and medications or conditions that increase serotonin syndrome risk.