A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of SAGE-217 in the Treatment of Adult Patients With Major Depressive Disorder

Major depressive disorder (MDD) is a disabling episodic condition, with a lifetime prevalence of 16.6% in the United States. Decreased gamma-aminobutyric acid (GABA) signaling has been linked to MDD. SAGE-217 is an investigational, oral neuroactive steroid and GABAA receptor positive allosteric modulator. A pivotal study of SAGE-217 in MDD (NCT03000530) demonstrated significant reductions in depressive symptoms. Here, we evaluate the efficacy and safety of two doses of SAGE-217 in a Phase 3, multicenter, double-blind, randomized, placebo-controlled trial (NCT03672175) in a larger MDD population.