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

NCT06372964 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: ITI-007-421
• Study Type: interventional
• Target: 384
• Locations: 3 countries
• Sites: 59

Brief 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

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

• Children's Depression Rating Scale-Revised (CDRS-R)

  The Children's Depression Rating Scale-Revised is an observer-rated, 17-item semi-structured scale for pediatric patients. The scale comprises cognitive, somatic, affective, and psychomotor symptoms of depression. Items are rated for severity on a 7-point scale (1 to 7) for 14 items and on a 5-point scale (1 to 5) for three items. Total scores range from 7 to 113.

  Week 6

Secondary Outcomes (1)

• Clinical Global Impression Scale-Severity (CGI-S)

  Week 6

Study Arms (2)

Lumateperone

EXPERIMENTAL

Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.

Drug: Lumateperone

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Lumateperone DRUG

Lumateperone administered orally, once daily.

Lumateperone

Placebo DRUG

Matching placebo administered orally, once daily.

Placebo

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Able to provide consent as follows:
• The Legally Authorized Representative (LAR) must provide written, informed consent.
• The patient must provide written assent;
• Male or female patients 10 to 17 years of age, inclusive;
• Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
• Subject has a lifetime history of at least one manic or hypomanic episode.
• Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
• CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
• Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.

You may not qualify if:

• Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:
• Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.
• Intellectual disability based on Investigator opinion and DSM-5 criteria
• Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
• Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;
• In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
• At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
• At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
• At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or
• The patient is considered to be an imminent danger to him/herself or others.

Sponsors & Collaborators

• Intra-Cellular Therapies, Inc.: lead

Study Sites (59)

Clinical Site

Dothan, Alabama, 36303, United States

RECRUITING

Clinical Site

Little Rock, Arkansas, 72204, United States

RECRUITING

Clinical Site

Anaheim, California, 92805, United States

RECRUITING

Clinical Site

Redlands, California, 92373, United States

RECRUITING

Clinical Site

Sacramento, California, 95817, United States

NOT YET RECRUITING

Clinical Site

San Diego, California, 92103, United States

RECRUITING

Clinical Site

West Covina, California, 91790, United States

RECRUITING

Clinical Site

Colorado Springs, Colorado, 80910, United States

RECRUITING

Clinical Site

Gainesville, Florida, 32607, United States

NOT YET RECRUITING

Clinical Site

Hialeah, Florida, 33012, United States

RECRUITING

Clinical Site

Homestead, Florida, 33030, United States

RECRUITING

Clinical Site

Miami, Florida, 33122, United States

RECRUITING

Clinical Site

Miami, Florida, 33125, United States

RECRUITING

Clinical Site

Miami, Florida, 33130, United States

RECRUITING

Clinical Site

Miami, Florida, 33134, United States

RECRUITING

Clinical Site

Miami, Florida, 33144, United States

RECRUITING

Clinical Site

Miami, Florida, 33165, United States

RECRUITING

Clinical Site

Miami, Florida, 33173, United States

RECRUITING

Clinical Site

Miami, Florida, 33176, United States

RECRUITING

Clinical Site

Miami, Florida, 33186, United States

RECRUITING

Clinical Site

Miami Gardens, Florida, 33056, United States

RECRUITING

Clinical Site

Miami Lakes, Florida, 33014, United States

RECRUITING

Clinical Site

Miami Lakes, Florida, 33016, United States

RECRUITING

Clinical Site

Miami Springs, Florida, 33166, United States

RECRUITING

Clinical Site

Orlando, Florida, 32803, United States

RECRUITING

Clinical Site

West Palm Beach, Florida, 33407, United States

RECRUITING

Clinical Site

Atlanta, Georgia, 30318, United States

RECRUITING

Clinical Site

Decatur, Georgia, 30030, United States

RECRUITING

Clinical Site

Lawrenceville, Georgia, 30046, United States

RECRUITING

Clinical Site

Savannah, Georgia, 31405, United States

RECRUITING

Clinical Site

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Clinical Site

Indianapolis, Indiana, 46202, United States

RECRUITING

Clinical Site

Baltimore, Maryland, 21229, United States

NOT YET RECRUITING

Clinical Site

Bloomfield Hills, Michigan, 48302, United States

RECRUITING

Clinical Site

Saint Charles, Missouri, 63304, United States

RECRUITING

Clinical Site

Lincoln, Nebraska, 68526, United States

RECRUITING

Clinical Site

Kinston, North Carolina, 28504, United States

NOT YET RECRUITING

Clinical Site

Avon Lake, Ohio, 44012, United States

RECRUITING

Clinical Site

Cincinnati, Ohio, 45219, United States

RECRUITING

Clinical Site

Garfield, Ohio, 44125, United States

RECRUITING

Clinical Site

Westlake, Ohio, 44145, United States

RECRUITING

Clinical Site

Oklahoma City, Oklahoma, 73112, United States

RECRUITING

Clinical Site

Oklahoma City, Oklahoma, 73116, United States

RECRUITING

Clinical Site

Austin, Texas, 78759, United States

RECRUITING

Clinical Site

Flower Mound, Texas, 76028, United States

RECRUITING

Clinical Site

Frisco, Texas, 75034, United States

NOT YET RECRUITING

Clinical Site

Houston, Texas, 77089, United States

RECRUITING

Clinical Site

Houston, Texas, 77090, United States

RECRUITING

Clinical Site

Richmond, Texas, 77407, United States

RECRUITING

Clinical Site

Richmond, Virginia, 23220, United States

RECRUITING

Clinical Site

Bellevue, Washington, 98007, United States

RECRUITING

Clinical Site

Everett, Washington, 98201, United States

RECRUITING

Clinical Site

Ahmedabad, 380008, India

RECRUITING

Clinical Site

Aurangabad, 431005, India

RECRUITING

Clinical Site

Nashik, 422005, India

RECRUITING

Clinical Site

Varanasi, 221005, India

RECRUITING

Clinical Site

Belgrade, 11000, Serbia

RECRUITING

Clinical Site

Niš, 18000, Serbia

RECRUITING

Clinical Site

Novi Sad, 21000, Serbia

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

lumateperone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

ITI Clinical Trials

CONTACT

646 440-9333; ITCIClinicalTrials@itci-inc.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: May 13, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (52); IN (4); SE (3)