NCT06372964

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 10 Years – 17 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	Lumateperone	Lumateperone administered orally, once daily.
DRUG	Placebo	Matching placebo administered orally, once daily.

Timeline

• Start date: 2024-05-13
• Primary completion: 2027-04-01
• Completion: 2027-05-01
• First posted: 2024-04-18
• Last updated: 2025-07-08

Locations

59 sites across 3 countries: United States, India, Serbia

Regulatory

• FDA-regulated drug study