LITHIUM IN AGGRESSIVE CHILDREN WITH CONDUCT DISORDER

锂用于有行为障碍的攻击性儿童

• 批准号: 3378214
• 负责人: MAGDA CAMPBELL
• 金额: $ 23.66万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-05-01 至 1994-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3378214
• 关键词: adolescence (12-20); aggression; antisocial personality; behavior disorders; behavior test; blood chemistry; carbamazepine; cognition; drug metabolism; drug quality /standard; hospital patient care; human subject; human therapy evaluation; mental disorder chemotherapy; middle childhood (6-11); placebos

Successful treatment of severe aggressiveness and explosiveness in children diagnosed as conduct disorder remains a serious challenge. The patients we wish to study have a history of chronic aggressive and explosive behavior and, after failing to respond to various outpatient treatments, including pharmacotherapy, have required hospitalization. Children diagnosed as conduct disorder with severe aggressiveness represent the largest single group of patients admitted to child psychiatric inpatient services. The majority of these patients do not respond adequately to currently available treatments and require placement in residential treatment centers. As adolescents and young adults, they tend to abuse drugs and/or alcohol and commonly will engage in antisocial behaviors and criminal acts. A more effective treatment than that now available would be of significant value in terms of both the public health and the general welfare. The loss of human potential and cost to society is immeasurable. We have replicated our earlier findings on the efficacy and safety of lithium carbonate in this type of child: lithium is statistically and clinically superior to placebo in reducing these target behaviors. However, in our ongoing study, 30% of the patient sample hand only slight or no reduction of aggressiveness and explosiveness while being treated with lithium based on the Clinical Global Consensus Rating. Also effects of lithium appeared to be weak or nonexistent for some measures (e.g.,POMS). Therefore alternate drugs have to be studied. The rationale for studying carbamazepine is twofold. First, carbamazepine has similar clinical profile to lithium, but was found to be effective is some patients who failed to respond to lithium. Second, carbamazepine is prescribed frequently to the type of child we wish to study, in the absence of strong evidence of efficacy and safety. We believe that the proposed research may further the field: treatment of severely aggressive and explosive children diagnosed as conduct disorder. The results from this study are applicable to other types of patients with severe disruptive behavior (including those who are mentally retarded. The objective of this proposal is to assess critically the efficacy and the safety of carbamazepine in 40 children, all hospitalized, ages 5 to 12 years, boys and girls, of normal intelligence, diagnosed as Conduct Disorder, Solitary Aggressive Type (DSM-III-R), and employing the DICA- R-C and DICA-R-P. This 7-week study will be double-blind and placebo controlled, using a parallel groups design. Following a 2-week placebo baseline period, children will be randomly assigned to carbamazepine or placebo treatment for 4 weeks; this will be followed by a one-week placebo period. Dosage will be individually regulated, not exceeding 1,000 mg/day. Behavioral ratings will be carried out in a variety of settings by several raters, independently employing a variety of instruments. including the Overt Aggression Scale (OAS). Drug effects will be assessed also on cognition in the laboratory, using a cognitive battery. Carbamazepine blood levels will be determined and correlated with behavioral response.

严重侵袭性和爆炸性的成功治疗 被诊断为品行障碍的儿童仍然是一个严重的挑战。这个 我们希望研究的患者有慢性侵袭性和 爆炸性行为，在对各种门诊患者没有反应后 包括药物治疗在内的治疗都需要住院治疗。 被诊断为品行障碍的儿童具有严重的攻击性 代表了收治儿童的最大单一群体 精神科住院服务。这些患者中的大多数都没有 对当前可用的治疗措施做出充分反应，并要求 安置在居民治疗中心。作为青少年和年轻的 成年后，他们往往滥用药物和/或酒精，通常会参与 反社会行为和犯罪行为。更有效的治疗方法 在这两个方面都具有重要的价值 公共卫生和公共福利。人类潜能的丧失 给社会带来的代价是不可估量的。 我们已经重复了我们早先关于药物有效性和安全性的研究结果。 碳酸锂在这类儿童中的作用：从统计学上讲，锂是 在减少这些靶向行为方面，临床疗效优于安慰剂。 然而，在我们正在进行的研究中，30%的患者只有手部样本 攻击性和爆炸性略有减少或没有减少 根据临床全球共识评级使用锂治疗。 此外，锂的影响对一些人来说似乎很弱或根本不存在。 衡量标准(例如POMS)。因此，必须研究替代药物。 研究卡马西平的理由有两个。第一, 卡马西平的临床特征与锂相似，但被发现 有效的是一些对锂离子没有反应的患者。第二, 卡马西平经常被开给我们想要的孩子 在没有强有力的有效性和安全性证据的情况下进行研究。我们 相信拟议的研究可能会进一步促进以下领域：治疗 被诊断为行为异常的严重攻击性和爆炸性儿童 无序。这项研究的结果也适用于其他类型的 有严重破坏性行为的患者(包括那些 智障。 这项建议的目标是严格评估疗效和 卡马西平在40名5-5岁住院儿童中的安全性 12岁，男孩和女孩，智力正常，被诊断为行为 障碍，孤独攻击型(DSM-III-R)，并使用DICA- R-C和DICA-R-P。这项为期7周的研究将是双盲和安慰剂。 对照，采用平行分组设计。在服用两周的安慰剂后 基线期间，儿童将被随机分配到卡马西平或 安慰剂治疗4周；之后将进行1周的治疗 安慰剂期。剂量由个人规定，不超过 1000毫克/天。行为评级将在各种不同的 由多个评分员设置，独立使用各种 乐器。包括公开攻击量表(OAS)。药物效应 也将在实验室中进行认知评估，使用认知 电池。卡马西平的血药浓度将被测定并关联 有行为反应。