What is lumateperone studying for bipolar depression in children and teens?

Lumateperone is being studied to evaluate its effects on bipolar depression in children and teens aged 10 to 17 years. This study aims to compare lumateperone with a placebo to better understand its impact on major depressive episodes associated with bipolar disorder. The trial is sponsored by Intra-Cellular Therapies, Inc.

Who may be eligible for this bipolar depression clinical trial?

Children and teens aged 10 to 17 years with a diagnosis of bipolar I or II disorder experiencing a current major depressive episode may be eligible. Both males and females can participate. Important factors include having had at least one manic or hypomanic episode and meeting specific depression severity scores. Please review eligibility criteria for more details.

Is there any cost to participate in this bipolar depression clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 3

Age: 10Years - 17Years

All Genders

ID06372964

Study Evaluating Oral Lumateperone Versus Placebo for Treating Bipolar Depression in Children and Teens Aged 10 to 17 Years

Led by Intra-Cellular Therapies, Inc. · Updated on 2026-07-31

384

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating lumateperone for treating bipolar depression in children and teens aged 10 to 17 years who are experiencing major depressive episodes linked to bipolar I or bipolar II disorder. This randomized, double-blind, placebo-controlled Phase 3 study aims to assess the effects of lumateperone compared to placebo in this pediatric population. Participants will be randomly assigned to receive either lumateperone or a matching placebo once daily for 6 weeks. The dosage for lumateperone is 42 mg for patients aged 13 to 17 years and 21 mg for those aged 10 to 12 years. The study includes three phases up to 2 weeks of screening to confirm eligibility, 6 weeks of double-blind treatment, and a 1-week safety follow-up visit after the last dose. During the study, participants will undergo assessments including the Childrens Depression Rating Scale-Revised CDRS-R at week 6 to measure depressive symptoms. Safety will be monitored throughout, with a follow-up visit approximately one week after treatment ends. The total participation duration covers screening, treatment, and safety follow-up, ensuring comprehensive evaluation of both efficacy and safety in this age group.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 10Years - 17Years

All Genders

Eligibility Criteria

You may qualify if you...

Legally Authorized Representative must provide written informed consent and patient must provide written assent
Male or female patients aged 10 to 17 years inclusive
Diagnosis of bipolar I or bipolar II disorder with a current major depressive episode without psychosis confirmed by K-SADS-PL
Lifetime history of at least one manic or hypomanic episode
Current major depressive episode lasting at least 4 weeks and less than 12 months
Children's Depression Rating Scale-Revised (CDRS-R) total score of 45 or higher with 5 or more on depressed feelings item at screening and baseline
Young Mania Rating Scale (YMRS) score of 15 or less with item 1 score of 2 or less at screening and baseline

You will not qualify if you...

Primary psychiatric diagnosis other than bipolar I or bipolar II disorder (except stable ADHD treatment)
Intellectual disability as assessed by investigator using DSM-5 criteria
Hospitalization for bipolar manic episode within 30 days before randomization
Improvement of 25% or more in CDRS-R total score between screening and baseline or CDRS-R below 45 at baseline
Significant risk for suicidal behavior as judged by investigator, including recent suicidal ideation or attempts and high scores on suicide-related items
Considered imminent danger to self or others

Research Team

Study Contact

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Study Evaluating Oral Lumateperone Versus Placebo for Treating Bipolar Depression in Children and Teens Aged 10 to 17 Years

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria