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(申请人提供)：在过去的二十年里， 研究调查表明，患有严重疾病的儿童 创伤性脑损伤是行为问题的高危因素， 适应能力，教育表现，以及精神病学 精神错乱。本组和对照组对重型颅脑损伤患儿的纵向随访 其他人则表明，这些问题无法解决加班问题，尽管至少 认知功能部分恢复。严重的颅脑损伤导致慢性 成人和儿童的社会情绪和行为后遗症，以及 与持续的家庭负担和痛苦有关。 不幸的是，人们对这些疾病的成功治疗知之甚少。 后遗症。虽然有报道称儿童的功能有所改善 重型颅脑损伤患者实施住院康复计划的效果 这些方案中的一些方案在方法上受到了挑战。药效 治疗方法已经过测试，但结果好坏参半。 拟议的试点项目的目的是审查以下方面的效果 阿立哌唑对儿童脑外伤后行为后遗症的影响阿立哌唑， 尽管仍在进行临床试验，但对 控制儿童的行为去抑制和自我调节问题 有思想和行为障碍。为了确定这一措施的有效性 药物治疗在减少行为问题和提高学习成绩中的作用 对于遭受严重脑外伤的儿童样本，我们将进行 随机、安慰剂对照、双盲交叉试验。孩子们 符合纳入标准的患者将随机接受为期两个月的 无论是积极的药物治疗还是安慰剂治疗，然后在 交叉手臂。在交叉研究阶段结束时，所有儿童 将被给予参加开放标签试验的选项，在此期间 他们将接受6个月的阿立哌唑治疗。随诊的目的 研究的阶段是确定药物效果是否持续 经久耐用。对行为、认知功能和家庭的评估 状态将在治疗前、两次交叉后进行 治疗，在为期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)检验时间的关联性 因为伤害和其他因素作为药物反应的预测因素和 确定其他与疗效相关的因素；(3)探索可能的药物治疗 其他儿童的行为和认知特征对家庭也有好处 功能；以及(4)调查药物影响的程度 在较长持续时间的开放标签试验期间持续。