1/4-Stimulant and Risperidone for Youth with Severe Physical Aggression

1/4-兴奋剂和利培酮，用于患有严重身体攻击的青少年

• 批准号: 8136056
• 负责人: MICHAEL George AMAN
• 金额: $ 50.46万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-15 至 2013-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8136056
• 关键词: Adverse event; Affective; Age; Aggressive behavior; Antipsychotic Agents; Attention deficit hyperactivity disorder; Back; Behavior; Behavior Therapy; Child; Child Behavior; Clinical; Cognition; Cognitive; Conduct Disorder; Desire for food; Diagnosis; Disruptive Behavior Disorder; Double-Blind Method; Drops; Educational process of instructing; Electrocardiogram; Ensure; Evidence based treatment; Exhibits; Glucose; Hostility; Hygiene; Interview; Investigation; Lipids; Measures; Methylphenidate; Monitor; Names; Neurologic; Ohio; Oppositional Defiant Disorder; Outcome; Outcome Measure; Parenting behavior; Parents; Participant; Pattern; Pharmaceutical Preparations; Pharmacotherapy; Physical aggression; Placebo Control; Placebos; Procedures; Prolactin; Protocols documentation; Public Health; Published Comment; Randomized; Recording of previous events; Reporting; Risperidone; Safety; Severities; Site; Sleep; Societies; Symptoms; Testing; Time; Training; Violence; Weight; Youth; analog; anti social; atypical antipsychotic; base; compare effectiveness; design; dexmethylphenidate; follow-up; impression; internal control; primary outcome; response; secondary outcome; teacher; treatment effect; treatment response

DESCRIPTION (provided by applicant): Disruptive behavior disorders (DBDs; conduct disorder and oppositional-defiant disorder) with severe aggression constitute a public health problem for which evidence-based treatment options are limited. Increasing numbers of youth with aggression are being treated with atypical antipsychotics without good evidence of safety or incremental advantage over safer stimulants. This double-blind, placebo-controlled, parallel groups study will compare the effectiveness of (a) parent training in behavior management (PMT) + placebo (PBO), (b) PMT + d-methylphenidate (d-MPH), and (c) PMT + d-MPH + risperidone (RIS) in children with severe aggression, primary DBDs, and comorbid ADHD. Participants must exhibit a clear history and current pattern of serious physical aggression (i.e., moderate or higher scores on the Modified Overt Aggression Scale (OAS-M), a Clinical Global Impressions (CGI) Scale Severity score of 4 or higher for aggression), and high scores on the on the Disruptive-Total of the Nisonger Child Behavior Rating Form (NCBRF) . The primary aims are to determine (a) if PMT + d-MPH are superior to PMT+ PBO and (b) if PMT + d-MPH + RIS are superior to PMT + d-MPH and to PMT + PBO. Secondary aims include determining whether type of aggression (reactive vs. proactive) moderates treatment response. Design: Two hundred sixteen children across 4 sites (Case Western Reserve, Ohio State, Pittsburgh, & Stony Brook) will be randomized to 9 weeks double-blind of PMT + PBO (n=72), PMT + MPH (n=72), or PMT + MPH + RIS (n=72). All groups will receive a 12-session course of carefully monitored, empirically-based PMT. Responders will be followed on their assigned treatments in a 12-week Extension, and all participants will be assessed at one year after baseline. Clinical change will be measured by (a) parent ratings on the NCBRF & ADHD Symptom Checklist (CL) ; (b) teacher ratings on the ADHD Symptom CL; (c) clinician interview of the child with OAS-M; (d) clinician CGI-Improvement score (CGI-I); and direct observations of child-parent behavior. The primary outcome measure is the NCBRF Disruptive Total score; secondary outcomes are CGI-I, response rate (NCBRF reduction of at least 25%, plus CGI-I score of 1 or 2), other NCBRF and ADHD Symptom Checklist subscales, and cognitive tests. Baseline score on the Antisocial Behavior Scale will assess type of aggression (reactive or proactive) as a potential moderator. AEs and tolerability will also be assessed. This study will assess the use of placebo, d-methylphenidate (Focalin), and d-methylphenidate plus risperidone (an atypical antipsychotic drug; brand name Risperdal) against the back-drop of behavior therapy which will be taught to the parents of participants. The participants will be children ages 6 to 12 years, inclusive, who have been diagnosed with a disruptive behavior disorder plus ADHD and who display significant aggressive behavior. Given the increasing rates and severity of violence in our society, this investigation will help to determine if drug therapy, combined with parent-provided behavior therapy, can reduce child aggression.

描述（由申请人提供）：严重侵略性的破坏性行为障碍（DBD；行为障碍和反对意识障碍）构成了公共卫生问题，这是一个有限的循证治疗选择。越来越多的侵略年轻人正在接受非典型抗精神病药的治疗，而没有良好的安全性或比更安全的兴奋剂的逐步优势。这项双盲，安慰剂控制的平行组研究将比较（a）行为管理中的父母培训（PMT） +安慰剂（PBO），（b）PMT + D-D-甲基苯甲甲酸酯（D-MPH）和（c）PMT + D-MPH + D-MPH + Risperidone（RIS）对患有严重侵略，初级DBD和ComorBD和ComorBID的儿童的有效性。参与者必须表现出严重的身体攻击的清晰历史和当前的模式（即，在经过改进的公开侵略量表（OAS-M）上得分中等或更高的分数，临床全球印象（CGI）量表的严重程度分数为4或更高的侵略性评分），以及在Nisonger儿童行为行为评分（NCBRF）的扰动性分数。主要目的是确定（a）如果PMT + D-MPH优于PMT + PBO，并且（B）如果PMT + D-MPH + RIS优于PMT + D-MPH，并且比PMT + PBO优于PMT + D-MPH。次要目的包括确定攻击类型（反应性与主动）是否适度治疗反应。设计：在4个地点（Case Western Reserve，Ohio State，Pittsburgh和Stony Brook）中，有2006名儿童将随机分为PMT + PBO（n = 72），PMT + MPH（n = 72）或PMT + MPH + MPH + RIS（n = 72）的9周双盲。所有小组都将获得12条课程的经验，基于经验的PMT。响应者将在为期12周的延期中遵循他们的分配治疗方法，所有参与者将在基准后一年进行评估。临床变化将通过（a）对NCBRF和ADHD症状清单（CL）的母公司评分来衡量； （b）ADHD症状CL的教师评分； （c）对OAS-M儿童的临床医生采访； （d）临床医生CGI改进评分（CGI-I）；并直接观察儿童行为。主要结果度量是NCBRF破坏性总分。次要结果是CGI-I，响应率（NCBRF降低至少25％，再加上CGI-I得分为1或2），其他NCBRF和ADHD症状清单量表和认知测试。反社会行为量表上的基线得分将评估攻击类型（反应性或主动）作为潜在的主持人。 AES和耐受性也将被评估。这项研究将评估安慰剂，D-甲基苯甲酸酯（Focalin）和D-甲基苯甲酸甲酯和利培酮（一种非典型的抗精神病药；品牌Risperdal）与行为疗法的背景，这将教给参与者的父母。参与者将是6至12岁的儿童，即包容性，他们被诊断出患有颠覆性行为障碍加多动症，并且表现出重大的侵略性行为。鉴于我们社会中暴力的发生率和严重程度的增加，这项调查将有助于确定药物治疗是否与父母提供的行为疗法相结合可以减少儿童侵略性。