Lumateperone for Pediatric Bipolar Depression

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Intra-Cellular Therapies, Inc.

Disqualifiers: Intellectual disability, Suicidal risk, others

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking ADHD medications, you must have been on a stable dose for 30 days before the trial and continue it throughout the study.

How is the drug Lumateperone unique for treating pediatric bipolar depression?

Lumateperone is unique because it is a newer medication that works differently from traditional treatments like lithium or divalproex, which are often used in combination. It offers a novel approach by targeting multiple neurotransmitter systems in the brain, potentially providing a more balanced treatment option for pediatric bipolar depression. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

This trial is for kids and teens who have been diagnosed with bipolar I or II disorder and are currently going through a major depressive episode. They must meet the specific diagnostic criteria outlined in a specialized interview called K-SADS-PL.

Inclusion Criteria

YMRS score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at Screening and Baseline.

CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline.

Able to provide consent as follows: The LAR must provide written, informed consent. The patient must provide written assent.

Exclusion Criteria

Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization.

Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes ADHD with stable treatment regimen for 30 days prior to screening.

Intellectual disability based on Investigator opinion and DSM-5 criteria.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 2 weeks

Treatment

Participants receive lumateperone or placebo for 6 weeks in a double-blind manner

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Lumateperone (Other)

Trial Overview The study tests Lumateperone, a new potential treatment for bipolar depression in young people, against a placebo (a substance with no active drug). Participants will be randomly assigned to either group without knowing which one they're in.

Participant Groups

Group I: Lumateperone Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

Matching placebo

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Recruited

10,700+

Findings from Research

In a study involving 347 children and adolescents aged 10 to 17 with bipolar depression, lurasidone significantly improved depressive symptoms compared to placebo, with a notable effect size of 0.45 after 6 weeks of treatment.

Lurasidone was well tolerated, showing minimal adverse effects on weight and metabolic parameters, and had similar discontinuation rates due to side effects as the placebo group, indicating its safety for this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study. DelBello, MP., Goldman, R., Phillips, D., et al.[2018]

Aripiprazole has demonstrated efficacy for preventing relapse in children aged 4-9 years with pediatric bipolar disorder, based on a randomized controlled trial, highlighting its potential as a long-term treatment option.

While lithium and anticonvulsants are effective for long-term symptom reduction, they are associated with gastrointestinal and neurological side effects, and second-generation antipsychotics (SGAs) like quetiapine may lead to weight gain and sedation, indicating the need for careful consideration of safety profiles in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practitioner review: Long-term pharmacological treatment of pediatric bipolar disorder. Díaz-Caneja, CM., Moreno, C., Llorente, C., et al.[2014]

In a study of 15 children and adolescents with bipolar disorder, 53% showed a moderate to marked response to divalproex treatment, indicating its potential efficacy for managing symptoms.

However, 40% of the patients discontinued treatment primarily due to side effects, with weight gain being the most common issue, highlighting the need for careful monitoring during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcome with divalproex in children and adolescents with bipolar disorder. Henry, CA., Zamvil, LS., Lam, C., et al.[2013]

In a study involving 90 youths aged 5 to 17 with bipolar disorder, combination therapy of divalproex sodium (DVPX) and lithium carbonate (Li) showed significant improvement in symptoms by week 8, indicating its effectiveness for acute treatment.

About 47% of participants achieved clinical remission by the end of the study, suggesting that this combination therapy can be a safe and effective option for managing juvenile bipolar disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination lithium and divalproex sodium in pediatric bipolarity. Findling, RL., McNamara, NK., Gracious, BL., et al.[2013]

Depression is more common than mania in children and adolescents with bipolar disorder, leading to significant functional disability, and requires a multimodal treatment approach combining medication and therapy.

Lithium and lamotrigine are effective medication options for treating pediatric bipolar depression, while quetiapine may not be more effective than a placebo; psychotherapy methods like IPSRT-A and CFF-CBT are also recommended as safe alternatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bipolar depression in pediatric populations : epidemiology and management. Cosgrove, VE., Roybal, D., Chang, KD.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Lurasidone in Children and Adolescents With Bipolar I Depression: A Double-Blind, Placebo-Controlled Study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Practitioner review: Long-term pharmacological treatment of pediatric bipolar disorder. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term outcome with divalproex in children and adolescents with bipolar disorder. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Combination lithium and divalproex sodium in pediatric bipolarity. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Bipolar depression in pediatric populations : epidemiology and management. [2021]