A Multicenter, Randomized, Double Blind, Placebo-controlled, Parallel Group, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Abilify® Tablet(Aripiprazole) as an Adjunctive Treatment in the Treatment of Major Depressive Episode Associated With Bipolar I or II Disorder
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Mean change in the Montgomery-Åsberg Depression Rating Scale total score
研究概览
简要总结
This is an 8-week, multicenter, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of aripiprazole as an adjunctive treatment with mood stabilizer for the treatment of patients (outpatients or inpatients) with type I or II bipolar disorder accompanied by major depressive episode, without any psychotropic features.
This study involves patients who are considered by the investigator not to have a proper improvement, despite receiving a mood stabilizer (lithium or valproic acid) for a sufficient (≥ 28 days) period of time during the current depressive episode.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 19 and < 70 years at the time of informed consent
- •Patients who are able to understand information required for providing a consent
- •Patients who have received a mood stabilizer (lithium or valproic acid)
- •Patients with bipolar I or II disorder accompanied by major depressive episode
- •Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 20 at both the screening and baseline visits
排除标准
- •Patients diagnosed with bipolar I or II disorder with mania, mixed or psychotropic features
- •Patients considered to have a high risk of suicide during the study period by the investigator based on current psychotic symptom and the patient's past medical history
研究组 & 干预措施
Abilify (Tablet)
干预措施: Abilify 2, 5, 10, 15mg (Tablet) (Drug)
Placebo of Abilify (Tablet)
干预措施: Placebo of Abilify 2, 5, 10, 15mg (Tablet) (Drug)
结局指标
主要结局
Mean change in the Montgomery-Åsberg Depression Rating Scale total score
时间窗: Week 8
Mean change in the MADRS total score from baseline to the end of the study(Week 8) The total score ranges from 0 to 60. Higher score indicates more severe depression.
次要结局
- Response rate(Week 8)
- Remission rate(Week 8)
- Mean change in the Clinical Global Impression-BP version Severity of Illness (Depression) score(Week 8)
- Percentage of subjects with Clinical Global Impression-BP version Severity of Illness (Depression) score of 1 or 2(Week 8)