NCT00122863已完成3 期
Duloxetine 60 to 120 mg Once Daily Compared With Placebo in the Prevention of Relapse in Generalized Anxiety Disorder
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 47
- 主要终点
- Assess the long-term maintenance of efficacy of duloxetine 60 to 120 mg QD compared with placebo by a comparison of the time to relapse among patients with GAD who responded to duloxetine during the open-label acute therapy phase after 22 to 26 weeks.
研究概览
简要总结
This is a clinical trial assessing the time to relapse of anxiety symptoms among patients with generalized anxiety disorder who have responded to duloxetine therapy.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with generalized anxiety disorder (GAD) in the absence of major depressive disorder (MDD). Patients must suffer from GAD and not from an adjustment disorder or anxiety disorder not otherwise specified (NOS). Symptoms of GAD should not be situational in nature.
排除标准
- •Any current and primary diagnosis other than GAD. Patients diagnosed with or who have a history of MDD within the past 6 months OR patients diagnosed with or who have a history of panic disorder, post-traumatic stress disorder (PTSD), or an eating disorder within the past year OR patients who have been diagnosed with obsessive- compulsive disorder (OCD), bipolar affective disorder, psychosis, factitious disorder or somatoform disorders during their lifetime.
- •History of alcohol or any psychoactive substance abuse of dependence (as defined in the DSM-IV-TR) within the past 6 months
- •Serious medical illness, including cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require hospitalization within 6 months, in the opinion of the investigator. Clinically significant laboratory abnormalities are those, that, in the judgement of the investigator, indicate a serious medical problem.
- •Acute liver injury (such as hepatitis) or severe cirrhosis (Child- Pugh Class C)
结局指标
主要结局
Assess the long-term maintenance of efficacy of duloxetine 60 to 120 mg QD compared with placebo by a comparison of the time to relapse among patients with GAD who responded to duloxetine during the open-label acute therapy phase after 22 to 26 weeks.
次要结局
- Self-reported anxiety symptomatology
- Pain
- Quality of Life
- Clinical Global Improvement and HAMA Factor scores
- Maintenance of Effect
研究者
研究点 (47)
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