Escitalopram (Lexapro) for the Treatment of Postpartum Depression

NCT00833469 | Completed Phase 4 Results

• 1 other identifier: 2008-P-001509
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postpartum Depression

Keywords

women; postpartum depression; anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Edinburgh Postnatal Depression Scale (EPDS)

  8 weeks

• Change in Beck Anxiety Inventory (BAI)

  8 weeks

Study Arms (1)

Escitalopram

EXPERIMENTAL

Flexible dose escitalopram 10mg

Drug: Escitalopram

Interventions

Escitalopram DRUG

Once daily by mouth

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Forest Laboratories: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• Center for Women's Mental Health Online Resource

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

We recruited only 7 patients out of a projected 20. Patients were not referred because they were breastfeeding or preferred to receive treatment from their primary care doctor. We also suspect that many women with PPD do not seek treatment at all.

Results Point of Contact

• Title: Dr. Marlene Freeman, MD
• Organization: Massachusetts General Hospital

mfreeman@partners.org

617-643-6403

Study Officials

• Marlene P Freeman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director, Center for Women's Mental Health

Study Record Dates

• First Submitted: January 29, 2009
• First Posted: February 2, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 6, 2014
• Results First Posted: August 6, 2014

Record last verified: 2014-08

Locations

US (1)