Escitalopram (Lexapro) for the Treatment of Postpartum Depression

Postpartum Depression Clinical Trial

— LexaproPPD  

Official title:

Escitalopram for the Treatment of Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833469
• Other study ID #: 2008-P-001509
• Status: Completed
• Phase: Phase 4
• First received: January 29, 2009
• Last updated: August 5, 2014
• Start date: January 2009
• Est. completion date: April 2011

Study information

• Verified date: August 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Drug:
• Escitalopram
Once daily by mouth

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Center for Women's Mental Health Online Resource