NCT00221429已完成3 期
Pediatric Bipolar Collaborative Mood Stabilizer Trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Young Mania Rating Scale (YMRS) & Clinical Global Impressions I (CGI-I)
研究概览
简要总结
This study compared the efficacy of lithium, divalproex, and placebo in treating the acute phase of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents.
详细描述
Primary Aim:
To compare the efficacy of lithium (LI), divalproex (DVP), and placebo (PBO) in the acute phase treatment of symptomatic bipolar I disorder, mixed or manic episode, in children and adolescents. Our hypothesis is that differential efficacy will be observed with the following predicted order of response: divalproex (DVP) = lithium (LI) > placebo (PBO).
Secondary Aims:
- To collect systematic safety data on the incidence of weight gain and the development of insulin resistance and hyperandrogenism in bipolar adolescent females treated with LI, DVP, or LI + DVP.
- To collect data on possible predictors of acute treatment response to the two active treatments.
- To provide descriptive information on the stability of acute phase response to monotherapy with either LI or DVP over 6 months of continuation phase treatment.
- To develop safety and efficacy data about the use of stimulant medications in these subject while treated with a mood stabilizer.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7.0 - 17 years of age
- •Bipolar I Disorder, mixed or manic episode, psychotic or non-psychotic, according to DSM IV criteria
- •Score of > 14 on the Y-MRS
- •Normal intelligence
- •Ability and willingness to provide assent and informed, written consent from at least one parent or legal guardian
- •No current general medical illnesses requiring medication
排除标准
- •A current or lifetime DSM-IV diagnosis of schizophrenia, autistic disorder, schizoaffective disorder, pervasive developmental disorder, or obsessive compulsive disorder
- •Patients with serious suicide risk
- •Concurrent cognitive-behavior therapy that is specifically focused on the child or adolescent's bipolar symptoms within 6 weeks of enrolling in this trial.
- •Any use of psychotropic agents within the preceding 2 weeks, including neuroleptics, monoamine oxidase inhibitors, stimulants, antidepressants, or depot neuroleptics or fluoxetine in the past month
- •Current or history in past 3 months of a DSM-IV diagnosis of Substance Abuse/Dependence or use of illicit drugs or alcohol in the past 3 weeks. Patients who have a positive drug screen at intake, who would otherwise be eligible for the study, will be given the opportunity to repeat the drug screen 3 weeks later. They will be excluded if the second drug screen is positive.
- •Pregnancy or sexually active females not using a reliable form of contraception
- •Previous adequate trial of either LI or DVP defined as; 3 weeks of DVP at serum levels between 75-125 OR dosage of at least 20 mg/kg; Lithium for at least 4 weeks at serum levels of .8 - 1.2 or dosage of at least 30 mg/kg.
- •Allergies to LI, DVP or chlorpromazine.
- •Bipolar subjects who are currently stable on mood stabilizers or atypical neuroleptics.
- •Bipolar subjects with Bipolar I disorder and ADHD who are stable on stimulants with or without concurrent mood stabilizers.
- •Inpatient hospitalization within 6 months prior to screening. Partial hospitalization is acceptable.
结局指标
主要结局
Young Mania Rating Scale (YMRS) & Clinical Global Impressions I (CGI-I)
时间窗: 8 weeks
次要结局
- CDRS & MRS(8 weeks)
研究者
研究点 (2)
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