Aripiprazole to Control Effects of TBI in Children (ACT)

阿立哌唑控制儿童 TBI 的效果 (ACT)

• 批准号: 6400647
• 负责人: JEFFREY L. BLUMER
• 金额: $ 21.49万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-07-13 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6400647
• 关键词: academic achievement; adolescence (12-20); antipsychotic agents; brain injury; child (0-11); child behavior disorders; clinical trials; cognition; family structure /dynamics; human subject; human therapy evaluation; mental disorder chemotherapy; patient oriented research

DESCRIPTION (provided by applicant): In the past two decades, numerous research investigations have demonstrated that children who sustain severe traumatic brain injury (TBI) are a high risk for problems in behavior, adaptive functioning, educational performance, as well as psychiatric disorders. Longitudinal follow-up of children with severe TBI by our group and others has shown that the problems fail to resolve overtime, despite at least partial recovery in cognitive function. Severe TBI leads to chronic social-emotional and behavioral sequelae in adults as well as children, and is associated with persisting family burden and distress. Unfortunately, little is known regarding successful treatment of these sequelae. While some improvement in function has been reported for children with severe TBI placed in-patient rehabilitation programs, the effectiveness of these programs has been challenged on methodological grounds. Drug treatments have been tested, but with mixed results. The purpose of the proposed pilot project is to examine the effects of aripiprazole on the behavioral sequelae of TBI in children. Aripiprazole, although still undergoing clinical trials, is particularly effective in controlling behavioral disinhibition and self-regulatory problems in children with thought and conduct disorders. To determine the effectiveness of this medication in reducing behavior problems and improving school performance in a sample of children who have sustained severe TBI, we will conduct a randomized, placebo controlled, double-blind crossover trial. Children who meet the inclusion criteria will be randomized to a two month regimen of either active medication or placebo, followed by a two month regimen in the crossover arm. At the end of the crossover phase of the study, all children will be given the option of participating in an open label trial during which they will receive aripiprazole for six months. The purpose of the follow-up phase of the study is to determine if the medication effects are sustained with prolonged use. Assessments of behavior, cognitive function, and family status will be carried out prior to treatment, after each of the two crossover treatments, and at the end of the 6-month open label trial. Specific goals are to: (1) determine the effectiveness of aripiprazole in controlling the targeted behavior problems; (2) examine associations of time since injury and other factors as predictors of drug responsiveness and to identify other correlates of efficacy; (3) explore possible medication benefits on other child behavioral and cognitive characteristics are on family functioning; and (4) investigate the extent to which drug effects are sustained during the longer-duration open label trial.

描述（由申请人提供）：在过去的二十年中，许多 研究调查表明，维持严重的孩子 创伤性脑损伤（TBI）是行为问题的高风险， 自适应功能，教育表现以及精神病学 疾病。我们小组对患有严重TBI的儿童的纵向随访， 其他人表明，尽管至少至少 认知功能的部分恢复。严重的TBI导致慢性 成人和儿童的社会情感和行为后遗症，是 与持续的家庭负担和困扰有关。 不幸的是，关于这些成功治疗的知之甚少 后遗症。虽然已经报告了儿童功能的一些改善 随着严重的TBI进行了住院康复计划，有效性 这些计划在方法论上受到了质疑。药品 治疗已被测试，但结果不同。 拟议的试点项目的目的是检查 在儿童TBI的行为后遗症上阿拉唑。阿立哌唑，， 尽管仍在进行临床试验，但在 控制儿童的行为抑制和自我调节问题 有思想和行为障碍。确定这一点的有效性 减少行为问题并改善学校表现的药物 持有严重TBI的儿童样本，我们将进行一次 随机，安慰剂控制的双盲跨界试验。孩子们 满足纳入标准将被随机分为两个月 活跃的药物或安慰剂，然后是两个月的治疗方法 跨界臂。在研究的跨界阶段结束时，所有儿童 将可以选择参加开放标签试验 他们将收到六个月的阿立哌唑。后续的目的 研究的阶段是确定药物效应是否持续 长时间使用。评估行为，认知功能和家庭 两次跨界后的每一个都将在治疗前进行状态 治疗，以及在6个月的开放标签试验结束时。 具体目标是：（1）确定阿立哌唑的有效性 控制目标行为问题； （2）检查时间的关联 由于受伤和其他因素是药物反应性的预测因素， 确定其他功效的相关性； （3）探索可能的药物 对其他儿童行为和认知特征的益处对家庭有 功能； （4）研究药物作用的程度 在长期开放标签试验中持续。