Study of Lumateperone in the Treatment of Patients With Bipolar Mania

This is a multicenter, randomized, double-blind, placebo-controlled, study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features (bipolar mania), with or without psychotic symptoms, according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).

NCT Number	NCT06462612
Lead Sponsor	Intra-Cellular Therapies, Inc.
Conditions	Bipolar Disorder, Manic
Enrollment	351 participants
Start Date	2024-07-17
Primary Completion	2026-05-15 (estimated)
Study Completion	2026-05-20 (estimated)
Updated on ClinicalTrials.gov	2026-07-24