Escitalopram (Lexapro) for the Treatment of Postpartum Depression

NCT ID: NCT00833469

Last Updated: 2014-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-04-30

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.

Detailed Description

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Conditions

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Postpartum Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Escitalopram

Flexible dose escitalopram 10mg

Group Type EXPERIMENTAL

Escitalopram

Intervention Type DRUG

Once daily by mouth

Interventions

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Escitalopram

Once daily by mouth

Intervention Type DRUG

Other Intervention Names

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Lexapro

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marlene P. Freeman, MD

Clinical Director, Center for Women's Mental Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marlene P Freeman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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http://www.womensmentalhealth.org

Center for Women's Mental Health Online Resource

Other Identifiers

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2008-P-001509

Identifier Type: -

Identifier Source: org_study_id

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