NCT00844857已完成4 期
Study to Assess the Efficacy and Safety of Olanzapine and Fluoxetine Combination Versus Placebo in Patients Ages 10-17 in the Treatment of Major Depressive Episodes Associated With Bipolar I Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 291
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8
研究概览
简要总结
The main goal of this study is to help answer the following research question(s) and not to treat the child's illness.
- Can this study drug make children with bipolar depression feel better?
- Does this study drug work better than a placebo (sugar pill)?
- Does this study drug cause side effects in children who take it?
- Is this drug safe to use in children? (The study drug is a mixture of olanzapine and fluoxetine)
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
- •Male or female inpatients or outpatients, 10-17 years of age, who have not reached their 18th birthday prior to screening. Patient must weigh at least 20 kilograms (kg) at screening.
- •Must meet diagnostic criteria for current major depressive episode of Bipolar I Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Version (DSM-IV-TR) and confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children-Present and Lifetime (K-SADS-PL)
- •Patients entering the study will also be scored by the Children's Depression Rating Scale-Revised (CDRS-R) (entry score of greater than or equal to 40) as well as the adolescent-structured Young Mania Rating Scale (YMRS) (entry score of less than or equal to 15 with YMRS Item 1 [elevated mood] score less than equal to 2).
排除标准
- •Patients will be excluded if they are, in the opinion of the investigator, actively suicidal
- •Have an acute, serious or unstable medical condition
- •Have clinically significant laboratory abnormalities
- •Have had one or more seizures of unclear etiology
- •Have a current or lifetime diagnosis of any of the following according to DSM-IV criteria: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition, unless there is substantive reason to believe patient was misdiagnosed
研究组 & 干预措施
Olanzapine/Fluoxetine Combination
Experimental
干预措施: Olanzapine Fluoxetine Combination (OFC) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Children's Depression Rating Scale Revised (CDRS-R) Total Score at Week 8
时间窗: Baseline, Week 8
CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning. Total scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, and scores of 40 to 60 indicate moderate depression. Least Square (LS) mean was adjusted for baseline, country, treatment, visit, and treatment times (\*) visit interaction.
次要结局
- Percentage of Participants With Treatment Emergent Suicidal Ideation or Behavior Up to Week 8(Baseline up to Week 8)
- Percentage of Participants With Remission Up to Week 8(Baseline up to Week 8)
- Change From Baseline in the YMRS Total Score at Week 8(Baseline, Week 8)
- Change From Baseline in the Clinical Global Impression Scale - Bipolar Version (CGI-BP) Score at Week 8(Baseline, Week 8)
- Change From Baseline in the CDRS-R Total Score Up to Week 8(Baseline, Week 8)
- Percentage of Participants With at Least One Incident of Worsening of Mania Up to Week 8(Baseline up to Week 8)
- Percentage of Participants With Response Up to Week 8(Baseline up to Week 8)
- Percentage of Participants in Each Improvement Category Up to Week 8(Baseline up to Week 8)
- Percentage of Participants With at Least One Treatment-Emergent Incident of Akathisia Up to Week 8(Baseline up to Week 8)
- Change From Baseline in Symptoms of Attention-Deficit/Hyperactivity Disorder Up to Week 8(Baseline up to Week 8)
- Change From Baseline in the Quality of Life Questionnaire for Children and Adolescents (KINDL) Parent Scale Up to Week 8(Baseline, Week 8)
研究者
研究点 (1)
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