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A Study of a Psilocybin Analog (CYB003) in Humans With Major Depressive Disorder (APPROACH)

Not yet recruitingRegisteredCTG

This Phase III randomised, double-blind, placebo-controlled trial (n=220) will study the efficacy, safety, and tolerability of CYB003 (16mg), a synthetic psilocybin analogue, compared to placebo as an adjunctive treatment for major depressive disorder (MDD).

Details

Randomised, quadruple-blind, parallel-group Phase III study (n≈220) comparing CYB003 16 mg given in two dosing sessions ~3 weeks apart versus matching placebo, adjunctive to a stable antidepressant and manualised psychological support.

Primary aim is to assess efficacy, safety, and tolerability in participants with moderate-to-severe MDD; key eligibility includes BMI ≤40 kg/m2 and exclusion for psychotic/bipolar disorders, recent high suicide risk, and recent psychedelic use.

Topics:Major Depressive Disorder (MDD)

Registry

Registry linkNCT06564818