Aripiprazole to Control Effects of TBI in Children (ACT)

描述（由申请人提供）：在过去的二十年里，许多 研究表明，患有严重精神分裂症的儿童， 创伤性脑损伤（TBI）是行为问题的高风险， 适应功能、教育表现以及精神病学 紊乱本研究组对严重TBI儿童的纵向随访， 另一些研究表明，这些问题无法随着时间的推移而得到解决，尽管至少 认知功能部分恢复严重的TBI导致慢性 成人和儿童的社会情绪和行为后遗症， 与持续的家庭负担和痛苦有关。 不幸的是，很少有人知道如何成功地治疗这些疾病。 后遗症虽然儿童的功能有所改善， 与严重的TBI放置住院病人康复计划，有效性 这些方案在方法上受到了质疑。药物 已经测试了治疗方法，但结果好坏参半。 拟议试点项目的目的是审查 阿立哌唑对儿童TBI行为后遗症的影响。阿立哌唑， 尽管仍在进行临床试验，但在 控制儿童的行为去抑制和自我调节问题 有思维和行为障碍为了确定这种方法的有效性， 药物治疗在减少行为问题和提高学校表现， 对于患有严重TBI的儿童样本，我们将进行 随机、安慰剂对照、双盲交叉试验。的儿童 符合入选标准的受试者将被随机分配至两个月的方案， 无论是活性药物或安慰剂，随后在两个月的方案， 交叉臂。在研究的交叉阶段结束时，所有儿童 将可选择参加开放标签试验， 他们将接受为期六个月的阿立哌唑治疗。后续行动的目的 研究的一个阶段是确定药物作用是否持续 长期使用。行为、认知功能和家庭评估 在治疗前、两次交叉后， 治疗，并在6个月的开放标签试验结束时。 具体目标是：（1）确定阿立哌唑在 控制目标行为问题;（2）检查时间关联 由于损伤和其他因素作为药物反应性的预测因子， 确定疗效的其他相关因素;（3）探索可能的药物 对其他儿童行为和认知特征的好处是家庭 （4）研究药物作用的程度。 在较长时间的开放标签试验期间持续。

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.