NCT00154362已完成4 期
A Multi-center, Randomized, Double-blind, Cross-over, Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Oxcarbazepine p.o. (300-1200 mg/Day) as Adjuvant Therapy for Impulsivity and Aggressive Behavior in Conduct Disorders in Adolescents
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 50
- 主要终点
- Percentage reduction on Impulsivity Rating Scale (IRS)
研究概览
简要总结
Conduct disorder is a group of psychiatric symptoms that can include clinical characteristics of impulsivity and aggressive behavior. This study will investigate the efficacy a safety of oxcarbazepine in the treatment of adolescents with conduct disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
- •Score >8 on the Impulsivity Rating Scale
排除标准
- •Other serious medical or psychiatric conditions excluding conduct disorder, oppositional defiant disorder, and disruptive behavior disorder not otherwise specified
- •Treatment with antiepileptic medications
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Percentage reduction on Impulsivity Rating Scale (IRS)
次要结局
- Percent reduction in the Modified Overt Aggression Scale (MOAS)
研究者
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