NCT00350857已完成4 期
A Phase IV, Multi-Center, Open-Label, Safety and Effectiveness Study of Extended-Release Carbamazepine in the Treatment of Mania in Children and Adolescents Aged 10-17 Years With Acute Manic or Mixed Bipolar I Disorder.
Validus Pharmaceuticals26 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2006年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 26
- 主要终点
- Safety and tolerability as assessed by the occurrence of treatment emergent adverse events and evaluations of clinical laboratory values, physical examinations, vital signs and ECG data after 6 months of treatment.
研究概览
简要总结
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Key Inclusion Criteria:
- •DSM-IV diagnosis of bipolar I disorder, most recent episode manic or mixed.
- •A lifetime history of bipolar disorder symptoms for at least 2 months.
- •YMRS score greater than or equal to
- •CGI-S score greater than or equal to
- •Male or female outpatient aged between 10-17 years old inclusive at the time of consent.
- •Functioning at an age-appropriate level intellectually, as deemed by the Investigator.
- •The subject has no co-morbid illness that could affect efficacy, safety, or tolerability or in any way interfere with the subject's participation in the study.
- •Must have a satisfactory medical assessment with no clinically significant and relevant abnormalities.
排除标准
- •Key Exclusion Criteria:
- •Current controlled or uncontrolled, co-morbid psychiatric diagnosis that could interfere with clinical assessments or study conduct.
- •A history of lack of therapeutic response or hypersensitivity to the study drug.
- •A greater than or equal to 50% reduction in YMRS between Screening and Baseline.
- •Acutely at risk for suicidal or violent behavior or a history of suicide attempts requiring medical intervention.
- •A history of aplastic anemia, agranulocytosis or bone marrow depression.
- •A history of seizure disorder, other than a single childhood febrile seizure.
- •A history of severe, unstable asthma.
- •Current hospitalization for psychiatric symptoms.
- •History of alcohol or other substance abuse or dependence.
- •Pregnant or lactating females.
- •Body weight less than or equal to 25 kg.
研究组 & 干预措施
Equetro active
Active Comparator
干预措施: Extended-Release Carbamazepine (Drug)
结局指标
主要结局
Safety and tolerability as assessed by the occurrence of treatment emergent adverse events and evaluations of clinical laboratory values, physical examinations, vital signs and ECG data after 6 months of treatment.
时间窗: 6 months
次要结局
- Reduction of bipolar symptoms as assessed by the Young Mania Rating Scale (YMRS), Clinical Global Impressions Scale (CGI) and Children's Depression Rating Scale (CDRS-S) after 6 months of treatment.(6 months)
研究者
研究点 (26)
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