drugset / Trial / NCT06462612

Study of Lumateperone in the Treatment of Patients With Bipolar Mania

NCT06462612

Phase 3 Recruiting 350 enrolled Intra-Cellular Therapies, Inc.
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2024-07-17
Primary completion
2026-05
Completion
2026-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumateperone Small molecule 42 mg Oral