Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
NCT ID: NCT06372964
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
384 participants
INTERVENTIONAL
2024-05-13
2027-05-31
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lumateperone
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.
Lumateperone
Lumateperone administered orally, once daily.
Placebo
Matching placebo
Placebo
Matching placebo administered orally, once daily.
Interventions
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Lumateperone
Lumateperone administered orally, once daily.
Placebo
Matching placebo administered orally, once daily.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
10 Years
17 Years
ALL
No
Sponsors
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Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Site
Dothan, Alabama, United States
Clinical Site
Little Rock, Arkansas, United States
Clinical Site
Anaheim, California, United States
Clinical Site
Redlands, California, United States
Clinical Site
Sacramento, California, United States
Clinical Site
San Diego, California, United States
Clinical Site
West Covina, California, United States
Clinical Site
Colorado Springs, Colorado, United States
Clinical Site
Gainesville, Florida, United States
Clinical Site
Hialeah, Florida, United States
Clinical Site
Homestead, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami, Florida, United States
Clinical Site
Miami Gardens, Florida, United States
Clinical Site
Miami Lakes, Florida, United States
Clinical Site
Miami Lakes, Florida, United States
Clinical Site
Miami Springs, Florida, United States
Clinical Site
Orlando, Florida, United States
Clinical Site
West Palm Beach, Florida, United States
Clinical Site
Atlanta, Georgia, United States
Clinical Site
Decatur, Georgia, United States
Clinical Site
Lawrenceville, Georgia, United States
Clinical Site
Savannah, Georgia, United States
Clinical Site
Chicago, Illinois, United States
Clinical Site
Indianapolis, Indiana, United States
Clinical Site
Baltimore, Maryland, United States
Clinical Site
Bloomfield Hills, Michigan, United States
Clinical Site
Saint Charles, Missouri, United States
Clinical Site
Lincoln, Nebraska, United States
Clinical Site
Kinston, North Carolina, United States
Clinical Site
Avon Lake, Ohio, United States
Clinical Site
Cincinnati, Ohio, United States
Clinical Site
Garfield, Ohio, United States
Clinical Site
Westlake, Ohio, United States
Clinical Site
Oklahoma City, Oklahoma, United States
Clinical Site
Oklahoma City, Oklahoma, United States
Clinical Site
Austin, Texas, United States
Clinical Site
Flower Mound, Texas, United States
Clinical Site
Frisco, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Houston, Texas, United States
Clinical Site
Richmond, Texas, United States
Clinical Site
Richmond, Virginia, United States
Clinical Site
Bellevue, Washington, United States
Clinical Site
Everett, Washington, United States
Clinical Site
Ahmedabad, , India
Clinical Site
Aurangabad, , India
Clinical Site
Nashik, , India
Clinical Site
Varanasi, , India
Clinical Site
Belgrade, , Serbia
Clinical Site
Niš, , Serbia
Clinical Site
Novi Sad, , Serbia
Countries
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Central Contacts
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Other Identifiers
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ITI-007-421
Identifier Type: -
Identifier Source: org_study_id
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