NCT00545675已完成4 期
Multi-center, Double-blind, Randomized, Comparative Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of Abilify and Depakote in 24-week Treatment of Mania in Patients With Bipolar Disorder Remitted After 6-week Treatment With Abilify and Depakote
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Time to recurrence of bipolar disorder from randomization
研究概览
简要总结
To demonstrate the difference between Abilify with Depakote vs. Placebo with Depakote in 24-week treatment in patients with remission status after Abilify with Depakote in the 6-week study of acute mania in patients with bipolar disorder
详细描述
Further study details as provided by Korea OIAA
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mania or mixed episode of bipolar disorder according to DSM-IV
- •Male and female between the age of 18 and 65 (In case of child-bearing women, negative pregnancy test results should be confirmed before the administration of the investigational drug and appropriate contraception be used. Pregnant and breast-feeding women cannot be included)
- •Patients who can consent to participate in this clinical trial
- •Patients who understand this trial and comply with all protocol requirements
- •Patients who fulfill the following remission criteria for bipolar disorder in the two consecutive evaluation performed every week at Week 6 of 6-week study and thereafter:
- •(Definition of remission: a score less than 12 on the YMRS total score and simultaneously a score less than 13 on the MADRS total score)
排除标准
- •Patients with the following clinical symptoms diagnosed using DSM-
- •Patients with the following clinical symptoms diagnosed using DSM-IV:
- •Delirium, dementia, amnestic or other cognitive disorders
- •Schizophrenia or schizoaffective disorder
- •Patients who do not respond to clozapine
- •Patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period
- •Patients diagnosed with substance-related disorder according to DSM-IV within the past 3 months (abuse, intoxication, dependency and/or withdrawal symptoms). The abuse of benzodiazepines is included with the exception of caffeine or nicotine.
- •Patients known to have allergy or hypersensitivity reaction to Abilify(aripiprazole) or other quinolinones
- •Patients at high risk of suicide attempt or with the history of murder or mental status test
- •Patients with the history of neuroleptic malignant syndrome
- •Patients with the past history which may cause serious adverse events that can affect the safety or efficacy evaluation during the clinical trial period
- •Patients with clinically significantly abnormal laboratory results, vital sign or ECG results
- •Pregnant women or child-bearing women who do not or cannot use appropriate contraception
- •Patients with the history of convulsive disorder
- •Patients judged to have decreased compliance to the investigational drugs during a 6-week trial period by an investigator
- •Patients who commit serious protocol violation during a 6-week trial
研究组 & 干预措施
1
Experimental
Abilify(aripiprazole) + Depakote(divalproate)
干预措施: Abilify(aripiprazole) (Drug)
2
Placebo Comparator
Divalproate + Placebo
干预措施: Depakote (divalproate) (Drug)
结局指标
主要结局
Time to recurrence of bipolar disorder from randomization
时间窗: Throughout the study
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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