NCT00545142已完成4 期
Multi-center, Single Arm, Open Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Co-administration of Abilify With Depakote in the 6-week Treatment of Acute Mania in Patients With Bipolar Disorder
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Changes in the YMRS total score from baseline to the end of 6-week study
研究概览
简要总结
To demonstrate the efficacy and safety of co-administration of Abilify(aripiprazole) with Depakote(divalproate) in the acute phase of 6-week treatment 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
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Mania or mixed episode of Bipolar disorder Bipolar disorder, mania or mixed episode according to DSM-IV
- •The periods of mania or mixed episode should be within 3 months, and YMRS score at enrollment be more than
- •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
排除标准
- •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 Ablify(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 vital sign or ECG results in the clinically significant abnormal laboratory test 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 given psychotropic medications (except benzodiazepines) one day before baseline visit
- •Patients treated with Fluoxetine for the last 4 weeks
- •Patients who participated in clinical trials with other investigational drugs for the last one month
- •Patients with the history of convulsive disorder
- •Patients with the history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.
结局指标
主要结局
Changes in the YMRS total score from baseline to the end of 6-week study
时间窗: Throughout the study
次要结局
- Changes in YMRS total scores from baseline to the end of 6-week study(Throughout the study)
研究者
研究点 (2)
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