Escitalopram (Lexapro) for the Treatment of Postpartum Depression
- Registration Number
- NCT00833469
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 7
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Escitalopram Escitalopram Flexible dose escitalopram 10mg
- Primary Outcome Measures
Name Time Method Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) 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).
- Secondary Outcome Measures
Name Time Method Change in Edinburgh Postnatal Depression Scale (EPDS) 8 weeks The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of \>9 is indicative of perinatal major depression.
Change in Beck Anxiety Inventory (BAI) 8 weeks Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States