RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2024-05-13

Study Completion:2027-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06372964

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Able to provide consent as follows: * The Legally Authorized Representative (LAR) must provide written, informed consent. * The patient must provide written assent; 2. Male or female patients 10 to 17 years of age, inclusive; 3. 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); 4. Subject has a lifetime history of at least one manic or hypomanic episode. 5. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration; 6. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline; 7. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.	1. 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. 2. Intellectual disability based on Investigator opinion and DSM-5 criteria 3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization; 4. 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; 5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or 1. 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; 2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or 3. At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or 4. The patient is considered to be an imminent danger to him/herself or others.

Inclusion Criteria

Exclusion Criteria

1. Able to provide consent as follows:
* The Legally Authorized Representative (LAR) must provide written, informed consent.
* The patient must provide written assent;
2. Male or female patients 10 to 17 years of age, inclusive;
3. 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);
4. Subject has a lifetime history of at least one manic or hypomanic episode.
5. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
6. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
7. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.

1. 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.
2. Intellectual disability based on Investigator opinion and DSM-5 criteria
3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
4. 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;
5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
1. 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;
2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
3. At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or
4. The patient is considered to be an imminent danger to him/herself or others.

Contacts and Locations

Study Contact

ITI Clinical Trials

CONTACT

646 440-9333

ITCIClinicalTrials@itci-inc.com

Study Locations (Sites)

Clinical Site

Anaheim, California, 92805

United States

Clinical Site

Sacramento, California, 95817

United States

Clinical Site

San Diego, California, 92103

United States

Clinical Site

Colorado Springs, Colorado, 80910

United States

Clinical Site

Gainesville, Florida, 32607

United States

Clinical Site

Hialeah, Florida, 33012

United States

Clinical Site

Miami Lakes, Florida, 33014

United States

Clinical Site

Miami Lakes, Florida, 33016

United States

Clinical Site

Miami Springs, Florida, 33166

United States

Clinical Site

Orlando, Florida, 32803

United States

Clinical Site

Atlanta, Georgia, 30318

United States

Clinical Site

Decatur, Georgia, 30030

United States

Clinical Site

Lawrenceville, Georgia, 30046

United States

Clinical Site

Savannah, Georgia, 31405

United States

Clinical Site

Chicago, Illinois, 60611

United States

Clinical Site

Indianapolis, Indiana, 46202

United States

Clinical Site

Baltimore, Maryland, 21229

United States

Clinical Site

Saint Charles, Missouri, 63304

United States

Clinical Site

Lincoln, Nebraska, 68526

United States

Clinical Site

Kinston, North Carolina, 28504

United States

Clinical Site

Avon Lake, Ohio, 44012

United States

Clinical Site

Cincinnati, Ohio, 45219

United States

Clinical Site

Garfield, Ohio, 44125

United States

Clinical Site

Oklahoma City, Oklahoma, 73112

United States

Clinical Site

Oklahoma City, Oklahoma, 73116

United States

Clinical Site

Austin, Texas, 78759

United States

Clinical Site

Frisco, Texas, 75034

United States

Clinical Site

Houston, Texas, 77089

United States

Clinical Site

Houston, Texas, 77090

United States

Clinical Site

Bellevue, Washington, 98007

United States

Collaborators and Investigators

Sponsor: Intra-Cellular Therapies, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-13

Study Completion Date2027-05

Study Record Updates

Study Start Date2024-05-13

Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

Bipolar Depression