Phase 4
N=5
Escitalopram (Lexapro) for the Treatment of Postpartum Depression
Postpartum Depression
Bottom Line
View on ClinicalTrials.gov: NCT00833469 ↗Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) — -21.33 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Escitalopram (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) |
-21.33 | — |
| SECONDARY Change in Edinburgh Postnatal Depression Scale (EPDS) |
-19.33 | — |
| SECONDARY Change in Beck Anxiety Inventory (BAI) |
-15.00 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00833469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.