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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06372964

Public ClinicalTrials.gov record NCT06372964. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 7, 2026, 9:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT06372964
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Enrollment
384 participants

Conditions and interventions

Interventions

  • Lumateperone Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
10 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 12, 2024
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027
Last update posted
Jul 7, 2025

2024 – 2027

United States locations

U.S. sites
52
U.S. states
18
U.S. cities
41
Facility City State ZIP Site status
Clinical Site Dothan Alabama 36303 Recruiting
Clinical Site Little Rock Arkansas 72204 Recruiting
Clinical Site Anaheim California 92805 Recruiting
Clinical Site Redlands California 92373 Recruiting
Clinical Site Sacramento California 95817 Not yet recruiting
Clinical Site San Diego California 92103 Recruiting
Clinical Site West Covina California 91790 Recruiting
Clinical Site Colorado Springs Colorado 80910 Recruiting
Clinical Site Gainesville Florida 32607 Not yet recruiting
Clinical Site Hialeah Florida 33012 Recruiting
Clinical Site Homestead Florida 33030 Recruiting
Clinical Site Miami Florida 33122 Recruiting
Clinical Site Miami Florida 33125 Recruiting
Clinical Site Miami Florida 33130 Recruiting
Clinical Site Miami Florida 33134 Recruiting
Clinical Site Miami Florida 33144 Recruiting
Clinical Site Miami Florida 33165 Recruiting
Clinical Site Miami Florida 33173 Recruiting
Clinical Site Miami Florida 33176 Recruiting
Clinical Site Miami Florida 33186 Recruiting
Clinical Site Miami Gardens Florida 33056 Recruiting
Clinical Site Miami Lakes Florida 33014 Recruiting
Clinical Site Miami Lakes Florida 33016 Recruiting
Clinical Site Miami Springs Florida 33166 Recruiting
Clinical Site Orlando Florida 32803 Recruiting
Clinical Site West Palm Beach Florida 33407 Recruiting
Clinical Site Atlanta Georgia 30318 Recruiting
Clinical Site Decatur Georgia 30030 Recruiting
Clinical Site Lawrenceville Georgia 30046 Recruiting
Clinical Site Savannah Georgia 31405 Recruiting
Clinical Site Chicago Illinois 60611 Not yet recruiting
Clinical Site Indianapolis Indiana 46202 Recruiting
Clinical Site Baltimore Maryland 21229 Not yet recruiting
Clinical Site Bloomfield Hills Michigan 48302 Recruiting
Clinical Site Saint Charles Missouri 63304 Recruiting
Clinical Site Lincoln Nebraska 68526 Recruiting
Clinical Site Kinston North Carolina 28504 Not yet recruiting
Clinical Site Avon Lake Ohio 44012 Recruiting
Clinical Site Cincinnati Ohio 45219 Recruiting
Clinical Site Garfield Ohio 44125 Recruiting
Clinical Site Westlake Ohio 44145 Recruiting
Clinical Site Oklahoma City Oklahoma 73112 Recruiting
Clinical Site Oklahoma City Oklahoma 73116 Recruiting
Clinical Site Austin Texas 78759 Recruiting
Clinical Site Flower Mound Texas 76028 Recruiting
Clinical Site Frisco Texas 75034 Not yet recruiting
Clinical Site Houston Texas 77089 Recruiting
Clinical Site Houston Texas 77090 Recruiting
Clinical Site Richmond Texas 77407 Recruiting
Clinical Site Richmond Virginia 23220 Recruiting
Clinical Site Bellevue Washington 98007 Recruiting
Clinical Site Everett Washington 98201 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06372964, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 7, 2025 · Synced May 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06372964 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →