Clinical Trial

Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania

Completed Phase 3
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Summary
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).
Protocol Amendment History 1 change
critical Trial completed 2026-07-25
Trial Details
NCT Number NCT06462586
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Bipolar Disorder, Manic
Enrollment 354 participants
Start Date 2024-06-19
Primary Completion 2026-02-24 (estimated)
Study Completion 2026-03-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-24