12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Primary Measure:Reduction in Depression Symptoms
研究概览
简要总结
- Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks
- Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression
详细描述
)Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks
- Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of bipolar disorder I or II according to M.I.N.I.
- •patient has signed informed consent
- •male, or female who is using effective birth control if of child bearing age
- •age 18 and above
- •currently in a depressed phase, with or without psychotic features, of the illness based on DSM-IV/MINI criteria
- •score of more than 19 on the MADRS
- •history of treatment refractory bipolar depression as defined by failure of the depressive episode to respond to a mood stabilizer alone or a combination of 2 or more mood stabilizers or a combination of a mood stabilizer and an antidepressant
排除标准
- •current liver disease,
- •illness precluding the use of depakote er
- •patients who have been treated with a DEP and AZP combination in the past
- •Alcohol/drug dependence in the past one month
- •CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
- •history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
- •thyroid dysfunction
- •unstable general medical condition
- •require antipsychotic other than abilify
研究组 & 干预措施
Aripiprazole
Aripiprazole open-label in doses ranging from 5-30mg QD adjunct to Divalproex 500-2500mg QD.
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Primary Measure:Reduction in Depression Symptoms
时间窗: up to 12 weeks
Primary efficacy will be assessed by the proportion of patients achieving a 50% reduction (range 0- 60, higher the number the more depressed) on the Montgomery Asberg Depression Rating Scale (MADRS) (defined as response) concomitant with a Clinical Global Impression Scale(CGI-S) improvement of 1 or 2 (range 0-7, higher the number the more severe the overall bipolar symptoms).
次要结局
未报告次要终点
研究者
Charles L. Bowden
Principal Investigator
The University of Texas Health Science Center at San Antonio