Aripiprazole in At-Risk Children With Symptoms of Bipolar Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Young Mania Rating Scale (YMRS)
研究概览
简要总结
The purpose of this study is to test the effectiveness and tolerability/safety of aripiprazole (Abilify) in children with subsyndromal symptoms of bipolar disorder who also have a parent with bipolar disorder and other family member with a mood disorder.
详细描述
This will be a double-blind, placebo-controlled, parallel-arm, randomized clinical trial that will last up to 12 weeks.
This placebo-controlled portion will be followed by a 6-week open label extension/stabilization phase. In order to be eligible for participation in the extension/stabilization phase, subjects must: 1) in the investigator's opinion have had no dose-limiting side effects likely to be attributable to aripiprazole (APZ); 2) participated in the blinded portion of the clinical trial for a minimum of 4 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatients ages 5-17 years (inclusive)
- •Patients, who in the investigator's opinion have substantial symptoms of mania, depression, or both within the past 2 weeks such that treatment with a pharmacological agent is warranted
- •Currently meets Diagnostic Statistical Manual of Mental Disorders (DSM-IV) criteria for either cyclothymia, or bipolar disorder not otherwise specified (BP NOS) based on the results of both a semi-structured diagnostic research assessment, Present and Lifetime Version (K-SADS-Present and Lifetime (PL) supplemented with sections from the Washington University K-SADS) (Geller et al., 2001; Kaufman et al., 1997) and a clinical interview with a child and adolescent psychiatrist.
- •Offspring of a parent with a bipolar spectrum disorder (based on the results of either the Mini International Neuropsychiatric Interview (MINI)(Sheehan et al., 1998) or the Family History Method (FH-RDC)(Andreasen et al., 1977)
- •Has another first or second degree relative with a mood disorder determined by the results of either the MINI or the FH-RDC
- •Has participated in at least 4 sessions of psychotherapy specifically focused on the symptoms/management of pediatric mood disorder and continues to have clinically significant symptomatology
排除标准
- •Patients who have a history of intolerance to APZ at doses of 0.1mg/kg/day
- •Patients who have experienced a manic episode with documented treatment with APZ monotherapy at a dose of 0.2 mg/kg/day
- •Patients with an active neurological/medical disorder for which treatment with APZ would be contraindicated
- •Patients with clinical evidence of autistic disorder, Asperger's disorder, Rett's syndrome or other pervasive developmental disorder
- •Patients with clinical evidence of mental retardation
- •Patients who are known to be allergic or hypersensitive to aripiprazole
- •Patients who are unable to swallow pills/capsules
- •Patients for whom the need for hospitalization during the course of the study appears likely
- •Patients who have started a new psychotherapeutic intervention within less than 4 weeks of randomization
- •Patients who have a general medical or neurological condition (including clinically significant abnormalities on screening laboratories) that may be considered to be the etiology of the patient's mood disorder
- •Patients who have a general medical or neurological condition for which treatment with an atypical antipsychotic would be contraindicated (e.g. tardive dyskinesia)
- •Patients who have a general medical or neurological condition that could interfere with the interpretation of clinical response to APZ treatment
- •Patients taking psychotropic agents (other than psychostimulants) within one week of baseline (2 weeks for fluoxetine; 3 days for psychostimulants)
- •Patients with a suicide attempt requiring medical/psychiatric care within the past 6 months
- •Has met DSM-IV criteria for drug/alcohol abuse or dependence within the past 6 months
- •Females who are currently pregnant or lactating
- •Sexually active females, who in the investigators' opinion are not using an adequate form of birth control
研究组 & 干预措施
Aripiprazole-Randomized Phase
Patients randomly assigned to aripiprazole received medication in pill form with dosing at 2mg, 5mg, 7mg, 10mg, 12mg or 15mg depending on their response.
干预措施: Aripiprazole (Drug)
Placebo-Randomized Phase
Patients randomly assigned to placebo received pills/dosing made to look identical to the aripiprazole.
干预措施: Placebo (Drug)
结局指标
主要结局
Young Mania Rating Scale (YMRS)
时间窗: Open-Label Extension - 6 weeks
The Young Mania Rating Scale (YMRS) has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. Each item o the YMRS is given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. There are well described anchor points for each grade of severity. Total score ranges from 0 to 60, with higher being more severe mania.
次要结局
- Children's Depression Rating Scale-Revised (CDRS-R )(Baseline)
- CDRS-R Children's Depression Rating Scale-Revised(Open-Label Extension - 6 weeks)
- Children's Global Assessment Scale (CGAS)(Open-Label Extension - 6 weeks)
- Clinical Global Impressions Scale (CGI-Severity)(Open-Label Extension - 6 weeks)
- Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale IV or (ARS-IV)(Open-Label Extension - 6 weeks)
研究者
Robert L Findling, MD
Director, Division of Child and Adolescent Psychiatry
University Hospitals Cleveland Medical Center