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Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Bipolar Depression Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), 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 2 weeks) during which patient eligibility will be assessed - Double-blind Treatment Period (6 weeks) during which all patients will be randomized to receive lumateperone 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 (SFU) visit approximately one week after the last dose of study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06372964
Study type Interventional
Source Intra-Cellular Therapies, Inc.
Contact ITI Clinical Trials
Phone 646 440-9333
Email ITCIClinicalTrials@itci-inc.com
Status Recruiting
Phase Phase 3
Start date April 2024
Completion date May 2027
View Details
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