The Cognitive Effects of Aripiprazole in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Effectiveness and cognitive effects
研究概览
简要总结
To look at the cognitive effects of abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder. To examine the safety, effectiveness and tolerability of abilify in children with a primary diagnosis of Attention Deficit Hyperactivity Disorder.
详细描述
This will be a prospective, open-label, 6-week trial of APZ in outpatient children 8-12 years of age with a primary diagnosis of ADHD free of other major psychopathology. The six-week treatment phase will be proceeded by a 1-3 week screening phase.
The study cohort will consist of 10 children with ADHD combined type and 10 children with ADHD predominantly inattentive type who complete the study.
Cognitive measures will be assessed prior to APZ therapy and after 6 weeks of APZ treatment.
Safety assessments and measures of ADHD symptomatology will be collected prior to and during APZ therapy.
While receiving APZ treatment, patients will be seen at baseline, Week 1,2,3,4, and 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatients ages 8-12 years (inclusive)
- •Currently meets DSM-IV (American Psychiatric Association, 1994) criteria for a primary diagnosis of ADHD (either predominantly inattentive type or combined type) based on the results of semi-structured diagnostic assessment (K-SADS-PL)(Kaufman et al., 1997) and based on the results of a clinical interview with a child and adolescent psychiatrist
- •Patients, who in the investigator's opinion, have substantial symptoms of ADHD for which pharmacotherapy is indicated
- •Has a guardian who has provided written informed consent to participate in this trial
- •Has provided written informed assent to participate in this study
排除标准
- •Patients who have a history of intolerance to APZ at a dose of 5 mg/day
- •Patients with a history of APZ allergy or hypersensitivity to APZ
- •Patients with an active or prior neurological/medical disorder for which treatment with APZ would be contraindicated (such as tardive dyskinesia or neuroleptic malignant syndrome)
- •Patients with clinical evidence of autistic disorder, Rett's syndrome or Asperger's syndrome
- •Patients with any bipolar spectrum disorder
- •Patients with any schizophrenia spectrum disorder
- •Patients with conduct disorder
- •Patients with post-traumatic stress disorder or generalized anxiety disorder
- •Patients with a substance abuse disorder
- •Females who are sexually active, pregnant or lactating
- •Patients with a suicide attempt requiring medical/psychiatric care within the past 6 months
- •Patient taking psychotropic agents within one week of baseline (3 days for psychostimulants, 2 weeks for fluoxetine)
- •Patients with evidence of mental retardation (I.Q. < 70) based on the results of the Peabody Picture Vocabulary Test- III (PPVT-III)(Dunn and Dunn, 1981)
- •Patients who have a general medical or neurological condition that could interfere with the interpretation of the clinical response to APZ treatment
- •Patients who are unable to swallow pills or capsules
- •Patients for whom the need for hospitalization during the course of the study appears likely
研究组 & 干预措施
Open label treatment with aripiprazole
After 1-3 week screening phase, entered six week open trial of aripiprazole initiated at 2.5mg/day. DOsing was increased weekly in 2.5mg increments in order to reach maximum dose of 10mg/d.
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Effectiveness and cognitive effects
时间窗: 6 weeks
To examine effectiveness and cognitive effects during open-label pilot
次要结局
未报告次要终点
研究者
Robert L Findling, MD
Director, Child and Adolescent Psychiatry
University Hospitals Cleveland Medical Center