NCT01429831已完成4 期
Aripiprazole for the Augmentation of Antidepressant Therapy: An Observational, Outpatients Study in Inadequate Responders Diagnosed With Major Depressive Disorder
Taiwan Otsuka Pharm. Co., Ltd1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- 17-Item Hamilton Depression Rating Scale (HAM-D17) score
研究概览
简要总结
The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in outpatients with major depressive disorder who have had inadequate response to antidepressants in Taiwan clinical practice.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients, either gender, 20-65 years of age
- •Patients diagnosed with major depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), who fulfill both the following criteria:
- •Having at least one and no more than three inadequate responses of antidepressants
- •HAM-D17 score ≥ 14
- •Willing and able to comply with the study procedure and sign a written informed consent
排除标准
- •Females who are pregnant/lactating or planning to be pregnant
- •Presence of personality disorder cluster B (dramatic, emotional or erratic disorders) or any psychotic symptomatology in the current depressive episode based on Investigators judgment
- •History of organic mental disorder within 1 year prior to the screening visit
- •Acute risk of suicide attempts within 3 months prior to the initiation of study treatment (HAM D-17 score item 3 ≥ 3)
- •Electroconvulsive therapy (ECT) for current episode
- •Past exposure to aripiprazole treatment or any investigational product (including drug and invasive medical device) within 4 weeks prior to the initiation of study treatment
- •History of substance / alcohol abuse within 1 year prior to the screening visit
- •Patient with any medical or psychotic feature, including the presence of significant abnormal laboratory values, which is considered not suitable for this study by Investigator
研究组 & 干预措施
Aripiprazole
Experimental
干预措施: Aripiprazole (Drug)
结局指标
主要结局
17-Item Hamilton Depression Rating Scale (HAM-D17) score
时间窗: Week 1, 2, 4 and 6
Primary effectiveness endpoint: - Change from baseline in HAM-D17 score at Week 6 Secondary effectiveness endpoints: 1. Change from baseline in HAM-D17 score at Week 1, 2 and 4 2. Response rate at Week 1, 2, 4 and 6 - Response rate: decrease in HAM-D17 total score of at least 50% 3. Remission rate at Week 1, 2, 4 and 6 - Remission rate: HAMD-17 score ≤ 7
次要结局
- Clinical Global Impression of Severity (CGI-S) score(Week 1, 2, 4 and 6)
- Sheehan Disability Scale (SDS) total score(Week 1, 2, 4 and 6)
- World Health Organization Quality of Life (WHOQOL-BREF) score(Week 6)
研究者
研究点 (1)
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