Back to search results

Lumateperone for Bipolar Depression in Children and Teens

This study is testing a medication called lumateperone to see if it can help children and teenagers with bipolar depression. Participants will receive either lumateperone or a placebo (an inactive substance that looks like the real medicine) once a day by mouth. We are looking for 384 participants between 10 and 17 years old who have been diagnosed with bipolar I or bipolar II disorder and are currently experiencing a major depressive episode. The main goal is to see how much symptoms improve after 6 weeks, measured by a special rating scale for depression (Children's Depression Rating Scale-Revised or CDRS-R). The current recruitment status is unclear.

Study design
This is a multicenter, randomized, double-blind, placebo-controlled study planning to enroll 384 participants. Participants will be randomly assigned to receive either lumateperone or a placebo.
What's involved
You would go through a screening period of up to 2 weeks, followed by a 6-week treatment period where you take the study medicine daily. There will also be a safety follow-up visit about one week after your last dose.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a safety follow-up visit approximately one week after their last dose of the study drug.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06372964

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

Recruiting
PHASE3Ages 10–17InterventionalTreatment
Intra-Cellular Therapies, Inc.
~384 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:LumateperonePlacebo

At a glance

Recruiting sites
37 of 68 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Children's Depression Rating Scale-Revised (CDRS-R)
Measured over Week 6

Conditions

Bipolar Depression

Explore related trials

Bipolar Disorder

Where it's being run

68 sites across 21 states
Florida18
Texas7
California5
Georgia4
Ohio4
Colombia4
India4
Serbia4

Study leadership

  • Intra-Cellular Therapies, Inc. Clinical Trial · STUDY_DIRECTOR · Intra-Cellular Therapies, Inc.

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Children's Depression Rating Scale-Revised (CDRS-R)Week 6

    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.