Lumateperone for Pediatric Bipolar Depression

Recruiting at 46 trial locations

Overseen By ITI Clinical Trials

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Intra-Cellular Therapies, Inc.

Disqualifiers: Intellectual disability, Suicidal risk, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

384 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called lumateperone to determine if it helps children and teens with bipolar depression feel better. Researchers aim to find out if this treatment can reduce major depressive episodes associated with bipolar I or II disorder. Participants will receive either lumateperone or a placebo (a pill with no active medicine) to compare the effects. This trial may suit children aged 10 to 17 who have bipolar disorder with current depressive episodes lasting between 4 weeks and 12 months and have experienced at least one past manic episode. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that Lumateperone is likely to be safe for pediatric patients?

Research has shown that lumateperone is generally safe and well-tolerated by patients. It treats bipolar depression and maintains a good safety record. One study compared lumateperone to a placebo and found it more effective in reducing depression symptoms.

Further research is examining its safety in younger patients. An ongoing study is assessing its safety over 26 weeks in children with conditions like schizophrenia and bipolar disorder, aiming to ensure its safety for long-term use in those aged 10 to 17.

Lumateperone is also approved for adults with similar conditions, indicating it has passed strict safety tests. While studies continue to evaluate its safety in children, current evidence suggests it is a well-tolerated option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bipolar depression?

Lumateperone is unique because it targets serotonin, dopamine, and glutamate systems in the brain, offering a different approach compared to traditional mood stabilizers and antipsychotics typically used for pediatric bipolar depression. Researchers are excited about lumateperone because it represents a novel mechanism of action that might provide effective symptom relief with potentially fewer side effects. This could mean a safer treatment option for young patients, who are particularly sensitive to the side effects of conventional medications.

What evidence suggests that Lumateperone might be an effective treatment for pediatric bipolar depression?

Research has shown that lumateperone, which participants in this trial may receive, can help reduce symptoms of bipolar depression. In earlier studies, patients who took lumateperone experienced significant improvements in their depression. For instance, one study found that patients felt much better compared to those who did not take the drug. Another study found that a 42 mg dose of lumateperone effectively reduced depressive symptoms and improved the overall severity of the illness. These findings suggest that lumateperone may offer benefits for people with bipolar depression. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Lumateperone

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.

How Is the Trial Designed?

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

Lumateperone is already approved in United States for the following indications:

Approved in United States as Caplyta for:

• Schizophrenia
• Bipolar I or II disorder (bipolar depression)

Who Is Running the Clinical Trial?

Intra-Cellular Therapies, Inc.

Lead Sponsor

Trials

42

Recruited

10,700+

Published Research Related to This Trial

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]

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 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 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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06372964

NCT06372964 | Multicenter Study of Lumateperone for the ...

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11580221/

Efficacy and safety of lumateperone for bipolar depression ...

Lumateperone was efficacious in reducing depressive symptoms in bipolar depression (SMDs = −0.36, 95% CI: −.59 to −.13). In treating schizophrenia, lumateperone ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06372964?intr=Lumateperone&rank=5

Multicenter Study of Lumateperone for the Treatment ...

This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs)

4.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2022/209500Orig1s006_Redacted.pdf

209500Orig1s006 CONTENTS - accessdata.fda.gov

evidence of effectiveness for bipolar disorder for lumateperone 42 mg. The primary and prespecified secondary endpoint efficacy results are ...

5.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/02698811251364389

Dose-response efficacy and safety of lumateperone in ...

In terms of efficacy, our results showed that lumateperone at a dose of 42 mg significantly improved depressive symptoms, global illness ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06229210

Study Details | NCT06229210 | Safety and Tolerability Trial ...

This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar ...