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Escitalopram (Lexapro) for the Treatment of Postpartum Depression

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postpartum Depression

Intervention: Escitalopram (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
Marlene P Freeman, MD, Principal Investigator, Affiliation: Massachusetts General Hospital

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.

Clinical Details

Official title: Escitalopram for the Treatment of Postpartum Depression

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

Primary outcome: Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary outcome:

Change in Edinburgh Postnatal Depression Scale (EPDS)

Change in Beck Anxiety Inventory (BAI)

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

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

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Center for Women's Mental Health Online Resource

Starting date: January 2009
Last updated: August 5, 2014

Page last updated: August 23, 2015

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