Status:
COMPLETED
Escitalopram (Lexapro) for the Treatment of Postpartum Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Forest Laboratories
Conditions:
Postpartum Depression
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00833469
Start Date
January 1 2009
End Date
April 1 2011
Last Update
August 6 2014
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114