Escitalopram (Lexapro) for the Treatment of Postpartum Depression
The purpose of this study is to determine whether women with postpartum 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...
Brief Summary
Official Title: “Escitalopram for the Treatment of Postpartum Depression”
The purpose of this study is to determine whether women with postpartum 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.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: November 2010
Intervention(s) in this Clinical Trial
- Drug: Escitalopram
- Once daily by mouth
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Escitalopram
- Flexible dose escitalopram 10mg
Outcome Measures for this Clinical Trial
Primary Measures
- Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
Secondary Measures
- Edinburgh Postnatal Depression Scale (EPDS)
- Time Frame: 8 weeks
Safety Issue?: No
- Time Frame: 8 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 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 Criteria:
- 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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Massachusetts General Hospital Other
Overall Clinical Trial Officials and Contacts
Marlene P Freeman, MD Principal Investigator Massachusetts General Hospital
Overall Contact: Stephanie D Connors, BS 617-724-6989 sdconnors@partners.org
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00833469
Study ID Number: 2008-P-001509
ClinicalTrials.gov Identifier: NCT00833469
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00833469
