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

Launched by INTRA-CELLULAR THERAPIES, INC. · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Lumateperone to see if it can help treat bipolar depression in children and teenagers aged 10 to 17. Bipolar depression is a condition where individuals experience extreme mood swings, including episodes of deep sadness or depression. To participate in the study, eligible participants must have a diagnosed case of bipolar I or II disorder and be currently experiencing a major depressive episode lasting between 4 weeks and less than a year. They will need to get permission from a parent or guardian, as well as provide their own agreement to join the study.

Participants in this study will be randomly assigned to receive either Lumateperone or a placebo (a treatment that doesn't contain the active medication) over a set period. This trial is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results. Throughout the study, participants will be monitored for their mood and overall mental health. This trial is important because it aims to find effective treatment options for young people struggling with bipolar depression, helping them feel better and improve their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Able to provide consent as follows:
• • 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:
• 1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:
• • 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.