NCT00617045撤回不适用
Duloxetine in the Treatment of Postpartum-onset and Non-Postpartum Onset Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.
研究概览
简要总结
The purpose of this study is to assess whether the antidepressant, duloxetine, is equally effective as a treatment for subjects who have a Postpartum Onset Depression compared to subjects who have an onset of Major Depressive Disorder prior to delivery. The hypothesis is that duloxetine will be as effective in subjects with Postpartum Major Depressive Disorder as in subjects with a Major Depressive Disorder.
详细描述
Study was terminated because of poor enrollment
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult female subjects age 18 and above if onset of depression within 4 weeks of delivery,or onset of depression antenatally either during pregnancy or before pregnancy
- •must score greater than or equal to 12 on the Edinburgh Postnatal Depression Scale
- •speak English or Spanish
- •have access to a telephone
- •provide written and verbal consent
排除标准
- •have current or lifetime psychosis
- •an unstable medical condition
- •hypertension
- •narrow-angle glaucoma
- •liver disease
- •seizure disorders
- •substance abuse disorders
- •have a known hypersensitivity to duloxetine or any of the active ingredients
- •are in need of inpatient hospital treatment with an excluded medication
- •adolescents under the age of 18
- •Medication Exclusion
- •other antidepressants
- •antipsychotic agents
- •quinolone antibiotics
- •Type 1C antiarrhythmics
- •daily benzodiazepines
- •Treatment with a monoamine oxidase inhibitor
研究组 & 干预措施
Duloxetine
Experimental
type of experimental agent
干预措施: duloxetine (Drug)
结局指标
主要结局
Change in depression severity compared to baseline scores on the IDS-C between the two subject groups.
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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