2/3-Atomoxetine Placebo and Parent Training in Autism

2/3-托莫西汀安慰剂和自闭症家长培训

基本信息

批准号：
8237016
负责人：
MICHAEL George AMAN
金额：
$ 35.07万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-06-01 至 2014-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8237016
关键词：
Address Adolescent Adverse effects Adverse event Attention Attention deficit hyperactivity disorder Autistic Disorder Behavior Behavior Therapy Child Cognitive Data Analyses Dose Double-Blind Method Exhibits FDA approved Fatigue Healthcare Home environment Hyperactive behavior Maintenance Measures Minor Modeling Nausea Neurocognitive Outcome Measure Parent-Child Relations Parents Performance Pharmaceutical Preparations Pharmacology Placebo Control Placebos Population Procedures Protein Structure Initiative Questionnaires Randomized Clinical Trials Research S-nitro-N-acetylpenicillamine Safety Schools Stomach Strattera Stress Subgroup Symptoms System Training active method analog atomoxetine autism spectrum disorder behavior measurement behavior observation comparison group experience follow-up improved inattention neglect open label presynaptic primary outcome psychopharmacologic psychosocial response standard care teacher

项目摘要

DESCRIPTION (provided by applicant): There have been relatively few randomized clinical trials of pharmacology for attention-deficit/hyperactivity (ADHD) in children with Autism Spectrum Disorders (ASD). Studies involving stimulant medications have generally found poorer response rates and higher rates of intolerable side effects than in typically developing children with ADHD. Atomoxetine (Strattera) was approved by the FDA in January 2003 for treatment of ADHD. A nonstimulant, it inhibits the presynaptic norephinephrine transporter. There have been only four studies (three open and one small double-blind) examining this medication in children with ASD. Behavioral treatments, such as training parents in the use of behavioral interventions (PMT), are also standard treatments for ADHD in typically developing children. While PMT also has long been used in ASD, it has rarely been studied in combination with psychopharmacologic treatment in this population. This proposal addresses four objectives: a) to conduct a double-blind, placebo-controlled, 10-week parallel-group comparison of atomoxetine (ATX) versus placebo on i) clinician- and parent-rated behavior, ii) direct observations of behavior, iii) cognitive/performance measures of attention, and iv) adverse events in 156 children with ASD (78 treated with ATX, 78 with placebo); b) to conduct a 10-week parallel-group comparison of PMT versus no-PMT on behavioral measures of compliance in 156 children with ASD (78 with PMT, 78 without PMT) c) to conduct a 10-week parallel-group comparison of combined (ATX plus PMT) vs. single treatment (PMT alone) on measures of compliance in 156 children with ASD; and d) to compare the long-term maintenance of efficacy, safety, and tolerability of ATX and PMT via an open-label 6-month extension trial of responders. Medication doses will be titrated against benefit and side effects over the first 6 weeks (ATX to a cap of 1.8 mg/kg/day). PMT will be 10 sessions, 1-1.5 hr. each, modeled on the RUPP Autism Network PMT. Data analyses will capitalize on the power of a 2 x 2 analysis where appropriate. Children with ASD have been neglected in pharmacological research, placing an enormous burden on health care and educational systems. This trial has the potential to provide answers regarding optimal treatment (both psychosocial and pharmacological) for a sizeable subgroup of children with ASD who experience symptoms of over activity and inattention.

描述（由申请人提供）：在自闭症谱系障碍儿童（ASD）的儿童（ASD）的注意力缺陷/多动症（ADHD）药理学的随机临床试验相对较少。涉及刺激性药物的研究通常发现反应率较差，无法忍受的副作用率更高，而在典型的ADHD儿童中。 Atomoxetine（Strattera）于2003年1月获得FDA批准用于治疗多动症。一种非刺激性，它抑制突触前去肾上腺素转运蛋白。在ASD儿童中，只有四项研究（三个开放式和1盲）检查了这种药物。行为治疗，例如培训父母在使用行为干预措施（PMT）方面，也是对典型成长儿童的ADHD的标准治疗方法。尽管PMT长期以来一直在ASD中使用，但很少与该人群的心理药物治疗结合研究。该提案解决了四个目标：a）进行双盲，安慰剂对照的，为期10周的平行组比较atomoxetine（ATX）与安慰剂与i）临床医生和父母评级的行为，ii）直接观察行为，iii）注意力的认知/表现度量，iv）156名ASD儿童的不良事件（用ATX治疗78名，78岁，安慰剂）； b）在156名ASD儿童（78 with pmt，78，无PMT）c）中对PMT与NO-PMT进行10周平行组比较，以进行10周的平行组比较合并（ATX加上PMT）与单一治疗（单独使用PMT）在156名ASD儿童中的依从性度量； d）通过对响应者进行的6个月延长试验进行ATX和PMT的疗效，安全性和耐受性的长期维护。药物剂量将在最初6周（ATX为1.8 mg/kg/day）滴定效果和副作用。 PMT将是10个会议，1-1.5小时。每个，以Rupp自闭症网络PMT为模型。数据分析将在适当的情况下利用2 x 2分析的能力。 ASD的儿童在药理学研究中被忽略，给医疗保健和教育系统带来了巨大的负担。该试验有可能为大量的ASD儿童亚组提供有关最佳治疗（心理社会和药理学）的答案，这些儿童经历了过度活动和注意力不集中的症状。