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Clinical Trial 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).


Clinical Trial Description

The study will be conducted in 3 phases: - Screening Period (up to 1 week) during which patient eligibility will be assessed. - Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio. - Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06462612
Study type Interventional
Source Intra-Cellular Therapies, Inc.
Contact ITI Clinical Trials
Phone (646) 440-9333
Email ITCIClinicalTrials@itci-inc.com
Status Not yet recruiting
Phase Phase 3
Start date July 2024
Completion date June 2026

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