An 8-week, Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 193
- 试验地点
- 1
- 主要终点
- Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
研究概览
简要总结
The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
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
- •Provision of informed consent by one or both parents or legal guardian and written assent by the patients before any study procedures are performed.
- •The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.
- •Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.
- •Patients must be able to swallow the study medication tablets.
排除标准
- •The patient must not have been diagnosed with Tourette's Disorder, Obsessive-Compulsive Disorder, acute Post-traumatic Stress Disorder, Panic Disorder, Autistic Disorder and/or Asperger's Disorder.
- •Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.
- •The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.
- •Patients who in your doctors judgement pose a current suicidal or homicidal risk.
研究组 & 干预措施
Quetiapine XR
干预措施: Quetiapine XR (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
时间窗: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57
Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113).
次要结局
- Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S(Change from Baseline to Day 57)
- Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).(Days 8 to 57)
- The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score(Days 8 to 57)
- CGI-BP-C Score at Final Assessment (Day 57)(Change from Baseline to day 57)
- The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness(Day 57)