Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Reduction in Pediatric Anxiety Rating Scale (PARS) Score
研究概览
简要总结
The main objective of this exploratory 8 week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants between 6 and 17 years of age.
- •Fulfills diagnosis of autism spectrum disorders by meeting DSM-IV-TR PDD diagnostic criteria of autistic disorder, Asperger's disorder, or PDD-NOS as established by clinical diagnostic interview.
- •Participants with a score of ≥60 on the Anxiety/Depression subscale of Child Behavior Checklist (CBCL) and CGI-Anxiety severity of ≥
- •Subjects can be on psychotropic drugs if they have been on the medication for at least 4 weeks prior to initiating study treatment and if they are on a stable dose.
- •Subjects with disruptive behavior disorders, mood, or psychosis will be allowed to participate in the study provided they do not meet any exclusionary criteria.
排除标准
- •Mental retardation (I.Q. <70)
- •DSM-IV-TR PDD diagnosis of Rett's disorder, and childhood disintegrative disorder.
- •History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month).
- •Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including: pregnant or nursing females, organic brain disorders, uncorrected hypothyroidism or hyperthyroidism, clinically significant abnormalities on ECG (e.g. QT prolongation, arrhythmia), history of renal or hepatic impairment.
- •Clinically unstable psychiatric conditions or judged to be at serious suicidal risk.
- •History of substance abuse (except nicotine of caffeine) within past 3 months or urine drug screen positive for substances of abuse.
- •Any other concomitant medication with primary central nervous system activity other than stable regimens for >2 weeks.
- •A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician.
研究组 & 干预措施
Buspirone
干预措施: Buspirone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction in Pediatric Anxiety Rating Scale (PARS) Score
时间窗: baseline to 8 weeks
Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by change from baseline. Responders are defined as ≥30% reduction in the Pediatric Anxiety Rating Scale (PARS).
Clinical Global Impression-Anxiety (CGI-Anxiety) Improvement Score
时间窗: baseline to 8 weeks
Primary outcome measure of efficacy will be assessed by reduction in anxiety symptom severity as measured by Clinical Global Impression-Anxiety (CGI-Anxiety). Responders are defined as a score of ≤2 on the improvement subscale (i.e., "much" or "very much improved").
次要结局
未报告次要终点
研究者
Gagan Joshi
Assistant Professor of Psychiatry, Harvard University
Massachusetts General Hospital