Escitalopram (Lexapro) for the Treatment of Postpartum Depression
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postpartum Depression
Intervention: Escitalopram (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Marlene P Freeman, MD, Principal Investigator, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: Escitalopram for the Treatment of Postpartum Depression
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcome: Change in Edinburgh Postnatal Depression Scale (EPDS)Change in Beck Anxiety Inventory (BAI)
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Center for Women's Mental Health Online Resource
Starting date: January 2009
Last updated: August 5, 2014
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