NCT00067262已完成3 期
A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Depakote ER for the Treatment of Bipolar Disorder in Children and Adolescents
Abbott16 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2003年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 16
- 主要终点
- Change from baseline to the final evaluation in Y-MRS score.
研究概览
简要总结
The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.
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
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current primary diagnosis of bipolar I disorder, mania or mixed type
- •Outpatient between 10 and 17 years of age
- •Young Mania Rating Scale score greater than or equal to 20 during screening/washout and at Day 1
排除标准
- •Axis I other than Attention Deficit Hyperactivity Disorder (ADHD), Obsessive Compulsive Disorder (OCD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), Panic Disorder; or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
- •Current manic episode is drug-induced or secondary to a medical disorder (e.g., anti-depressants, hyperthyroidism)
- •Expected to require hospitalization for the current manic episode
- •Participation in psychotherapy that was started within the past 3 months, or if any significant changes are anticipated
- •Has taken atomoxetine or has taken allowed stimulant medication that has not been stable for at least 3 months prior to Day 1, or a dosage adjustment is expected during the study, or that may worsen mood symptoms
- •Unable to swallow tablets
- •Has received depot psychoactive medication within one inter-injection interval of Day 1
- •Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine, barbiturates, benzodiazepines or amphetamines
- •History of alcohol or substance dependence within past 3 mos. or substance abuse within past month
- •History of failed treatment on adequate Depakote (DR or ER) for a manic episode within past 12 months
- •Has taken Depakote (DR or ER) regularly for the current manic episode
- •Has serious violent, homicidal, or suicidal ideation
结局指标
主要结局
Change from baseline to the final evaluation in Y-MRS score.
次要结局
- Vital signs
- Adverse events
研究者
研究点 (16)
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