Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients (NCT06372964) | Clinical Trial Compass
RecruitingPhase 3
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
United States384 participantsStarted 2024-05-13
Plain-language summary
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).
Who can participate
Age range10 Years – 17 Years
SexALL
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Inclusion criteria
✓. Able to provide consent as follows:
✓. Male or female patients 10 to 17 years of age, inclusive;
✓. 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);
✓. Subject has a lifetime history of at least one manic or hypomanic episode.
✓. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
✓. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
✓. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.
Exclusion criteria
✕. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:
✕. Intellectual disability based on Investigator opinion and DSM-5 criteria
✕. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
✕. 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;
✕. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
✕. 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;
✕. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
✕. At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or