Biomarkers in Autism of Aripiprazole and Risperidone Treatment (BAART)

阿立哌唑和利培酮治疗自闭症的生物标志物 (BAART)

基本信息

批准号：
8137059
负责人：
C Lindsay LINDSAY DEVANE
金额：
$ 65.15万
依托单位：
MEDICAL UNIVERSITY OF SOUTH CAROLINA
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-03 至 2015-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8137059
关键词：
17 year old Academic Medical Centers Adolescent Adverse event Antipsychotic Agents Autistic Disorder Behavior Biological Markers Biometry Blinded Brain-Derived Neurotrophic Factor Characteristics Child Clinical Clinical Trials DNA DSM-IV Data Data Analyses Diagnostic Double-Blind Method Dropout Drowsiness Drug Monitoring Epidemiology FDA approved Faculty Gender Gene Targeting Genomics Head Hospitals Intervention Lead Measures Medical Monitor Multi-Institutional Clinical Trial Outcome Patients Pediatric Hospitals Pediatrics Pharmaceutical Preparations Pharmacogenomics Phenotype Placebos Plasma Predictive Value Prolactin Protocols documentation Psychiatry Psychosocial Assessment and Care Race Randomized Randomized Controlled Clinical Trials Recording of previous events Research Research Personnel Risperidone Safety Serum Single Nucleotide Polymorphism South Carolina Symptoms System Testing Therapeutic Time Treatment Protocols Universities Weight Weight Gain Weights and Measures active method aripiprazole atypical antipsychotic autism spectrum disorder blind drug metabolism evidence base evidence based guidelines experience receptor binding response trait treatment duration

项目摘要

DESCRIPTION (Provided by Applicant): The Biomarkers in autism of aripiprazole and risperidone treatment (BAART) project will provide evidence-based guidance in the selection and monitoring of drug treatment of autism. BAART involves three academic centers across South Carolina, with expertise in phenotyping patients with autistic spectrum disorders, assessing patient response in clinical trials, and expertise in pharmacogenomic research. Although the FDA has approved use of the antipsychotic drug risperidone for irritability associated with autistic disorder, a moderate response rate in pivotal clinical trials and concerns over tolerability and weight gain can force clinicians to select alternative drug treatments, for which evidence-based support is sparse. BAART will assess predictors of efficacy, tolerability, and safety in 200 children five to seventeen years old with autistic disorder (AD) during a double-blind, randomized ten week treatment period with either risperidone or aripiprazole following a two-week single-blind placebo period. Responders who complete the study may continue with medication treatment for three months. Factors considered will include 1) psychiatric history; 2) symptom response; 3) psychosocial support; 4) measures of tolerability; 5) serum prolactin and brain-derived neurotrophic factor concentration; and 6) a variety of single nucleotide polymorphisms related to target genes for drug disposition and transport, response, and tolerability. Data analysis will allow assessment of gender, race, and multiple biomarkers for their predictive value on the clinical course and outcome to treatment with two widely used pharmacologic interventions for AD. The BAART project will result in evidence-based guidelines for selection and monitoring of drug treatment of children and adolescents with AD. PROJECT NARRATIVE: Autism occurs in approximately 1 in 150 children. The investigators propose a multi-center clinical trial to provide evidence-based guidance in the selection and monitoring of durg treatment of autism.

描述（由申请人提供）：Aripiprazole和Risperidone治疗（BAART）项目的自闭症生物标志物将在选择和监测自闭症药物治疗的基于证据的指导。巴特涉及整个南卡罗来纳州的三个学术中心，在表型患有自闭症谱系障碍的患者方面具有专业知识，评估了临床试验中的患者反应以及药物基因组研究方面的专业知识。尽管FDA已批准使用抗精神病药物利培酮与自闭症疾病相关的易怒性，但关键临床试验中的中等缓解率以及对耐受性和体重增加的担忧可以迫使临床医生选择替代药物治疗。 Baart将评估200名五至十七岁儿童的疗效，耐受性和安全性的预测指标时期。完成研究的响应者可以继续进行药物治疗三个月。所考虑的因素将包括1）精神病史； 2）症状反应； 3）社会心理支持； 4）耐受性的措施； 5）血清催乳素和脑衍生的神经营养因子浓度； 6）与靶基因有关的多种单核苷酸多态性，用于药物处置和运输，反应和耐受性。数据分析将允许评估性别，种族和多种生物标志物，以了解其在临床过程中的预测价值，并通过两种广泛使用的AD药理干预措施进行治疗。 BAART项目将制定基于证据的指南，以选择和监测AD儿童和青少年的药物治疗。项目叙述：自闭症发生在150名儿童中大约有1个。研究人员提出了一项多中心临床试验，以在选择和监测自闭症治疗的选择和监测基于证据的指导。