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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 384
- 试验地点
- 71
- 主要终点
- Children's Depression Rating Scale-Revised (CDRS-R)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo
Matching placebo
干预措施: Placebo (Drug)
Lumateperone
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.
干预措施: Lumateperone (Drug)
结局指标
主要结局
Children's Depression Rating Scale-Revised (CDRS-R)
时间窗: 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.
次要结局
- Clinical Global Impression Scale-Severity (CGI-S)(Week 6)