NCT00733668已完成2 期
An Open-Label, Non-Comparative, Multi-Centre, Phase II Prospective Trial to Assess the Efficacy of Quetiapine Fumarate Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) in SSRI-Resistant Major Depressive Disorder.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 试验地点
- 4
- 主要终点
- The Montgomery-Asberg Depression Scale (MADRS) score
研究概览
简要总结
An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inform consent
- •Male and female, age between 18 and 65 years.
- •Naïve to any atypical antipsychotic
- •A diagnosis of major depressive disorder
排除标准
- •No use of fluvoxamine
- •Patients with a history of bipolar I or II disorder
- •Diagnosis of psychotic major depression disorder
结局指标
主要结局
The Montgomery-Asberg Depression Scale (MADRS) score
时间窗: Visit 1 - > 5
次要结局
- The Brief psychiatric Rating Scale (BPRS) scoreThe Clinical Global impression (CGI) scorePatient reported outcomes (PROs)(Visit 1 - > 5 (1 week between each visit))
- Sheehan Disability Scale (SDS) score(Visit 1 - > 5 (1 week between each visit))
- The Symptom Checklist 90 Revisred (SCL-90-R) score(Visit 1 - > 5 (1 week between each visit))
研究者
研究点 (4)
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