Escitalopram (Lexapro) for the Treatment of Postpartum Depression

Study Overview
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Brief Summary
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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.

Official Title
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Escitalopram for the Treatment of Postpartum Depression

Conditions
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Postpartum Depression

Intervention / Treatment
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* Drug: Escitalopram


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram<br>Flexible dose escitalopram 10mg | Drug: Escitalopram<br>* Once daily by mouth<br>* Other names: Lexapro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) | 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). | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Edinburgh Postnatal Depression Scale (EPDS) | 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. | 8 weeks | 
| Change in Beck Anxiety Inventory (BAI) | 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). | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women, postpartum depression, anxiety