Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression. Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks. This six-week double-blind treatment period is followed by an open-label treatment period of six months duration. This study is sponsored by Abbott Laboratories.
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
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must give consent to participate in the study and sign and date the IRB approved written informed consent form prior to the initiation of any study procedures
- •Subject must be between the ages of 18 and 70
- •Subject must have a diagnosis of bipolar I or II.
- •Subject must be currently depressed as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
- •Subject must have a baseline Montgomery-Asberg Depression Scale (MADRS) score of >19 and Young Mania Rating Scale (YMRS) score of <12
- •Women of childbearing potential must be nonpregnant/nonlactating and using adequate contraception if sexually active
- •Subject must not be using any concomitant psychotropic medications during the acute phase except prn benzodiazepines
排除标准
- •Subjects lacks the capacity to provide informed consent
- •Subject has currently or previously used divalproex or Dvpx-ER
- •Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
- •Subject has any alcohol, cocaine, or cannabis dependence within 3 months of study entry
- •Subject has any cocaine, hallucinogens, opiates, crystal methamphetamine, or MMDA abuse within 3 months of study entry
研究组 & 干预措施
Divalproex Sodium ER
干预措施: Divalproex Sodium ER (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Acute phase (week0-week6)
MADRS total scores range from 0-60, where higher scores are indicative of more depression.
次要结局
- Change in Short Form Health Survey (SF-36) Mental Component Summary Score(Acute phase (week0-week6))
- Change in Young Mania Rating Scale (YMRS) Total Score(Acute phase (week0-week6))
- Change in General Behavior Inventory (GBI) Depression Scale Score(Acute phase (week0-week6))
- Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score(Acute phase (week0-week6))
- Change in Hamilton Anxiety Rating Scale (HAMA) Total Score(Acute phase (week0-week6))
- Change in Short Form Health Survey (SF-36) Physical Component Summary Score(Acute phase (week0-week6))
研究者
Keming Gao
Director, Mood and Anxiety Clinic
University Hospitals Cleveland Medical Center