Escitalopram for the Treatment of Postpartum Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to determine whether women with postpartum major depressive disorder (MDD) will experience a significant decrease in depressive symptoms from baseline over an eight-week treatment intervention with escitalopram (Lexapro). Also, to determine whether women with postpartum MDD will experience a significant decrease in anxiety symptoms.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ages 18 to 45 years old
- •Subjects must meet criteria for a major depressive episode with symptoms developing within three month of live childbirth
- •Subjects must present within six months of childbirth
- •MADRS score >15
- •BAI score >10
- •Subjects will be able to be treated on an outpatient basis
- •Subjects will be able to provide written informed consent
排除标准
- •Subjects who have taken any psychotropic medication, including antidepressants and anti-anxiety medication, within the past two weeks (with the exception of non-benzodiazepine medications used for sleep, including trazodone, zolpidem, eszopiclone, etc)
- •Suicidal ideation with active plan or intent, as determined by the investigator
- •Presence of psychotic symptoms or homicidal ideation
- •History of mania or hypomania
- •Pregnant or breastfeeding
- •Presence of chronic depression or dysthymia, or chronic or treatment resistant anxiety disorders, as determined by investigator
- •Active alcohol/substance abuse currently or within the past year
- •Abnormal TSH, severe anemia, or uncontrolled hypertension
研究组 & 干预措施
Escitalopram
Flexible dose escitalopram 10mg
干预措施: Escitalopram (Drug)
结局指标
主要结局
Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 8 weeks
The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).
次要结局
- Change in Edinburgh Postnatal Depression Scale (EPDS)(8 weeks)
- Change in Beck Anxiety Inventory (BAI)(8 weeks)
研究者
Marlene P. Freeman, MD
Clinical Director, Center for Women's Mental Health
Massachusetts General Hospital