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

NCT06372964 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2025-07-08

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Lumateperone

Lumateperone administered orally, once daily.

DRUG

Placebo

Matching placebo administered orally, once daily.

Sponsors & Collaborators

  • Intra-Cellular Therapies, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-13
Primary Completion
2027-04-30
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States
  • India
  • Serbia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06372964 on ClinicalTrials.gov