A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
Overview
- Phase
- Phase 3
- Intervention
- Lumateperone
- Conditions
- Bipolar Depression
- Sponsor
- Intra-Cellular Therapies, Inc.
- Enrollment
- 384
- Locations
- 1
- Primary Endpoint
- Children's Depression Rating Scale-Revised (CDRS-R)
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief 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).
Detailed Description
The study will be conducted in 3 phases: * Screening Period (up to 2 weeks) during which patient eligibility will be assessed * Double-blind Treatment Period (6 weeks) during which all patients will be randomized to receive lumateperone or placebo in 1:1 ratio. * Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately one week after the last dose of study drug.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Able to provide consent as follows:
- •The Legally Authorized Representative (LAR) must provide written, informed consent.
- •The patient must provide written assent;
- •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:
- •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.
- •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
- •The patient is considered to be an imminent danger to him/herself or others.
Arms & Interventions
Lumateperone
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.
Intervention: Lumateperone
Placebo
Matching placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Children's Depression Rating Scale-Revised (CDRS-R)
Time Frame: Week 6
The Children's Depression Rating Scale-Revised is an observer-rated, 17-item semi-structured scale for pediatric patients. The scale comprises cognitive, somatic, affective, and psychomotor symptoms of depression. Items are rated for severity on a 7-point scale (1 to 7) for 14 items and on a 5-point scale (1 to 5) for three items. Total scores range from 7 to 113.
Secondary Outcomes
- Clinical Global Impression Scale-Severity (CGI-S)(Week 6)