Escitalopram (Lexapro) for the Treatment of Postpartum Depression - Full Text View

Escitalopram (Lexapro) for the Treatment of Postpartum Depression (LexaproPPD)

This study is currently recruiting participants.

Verified July 2011 by Massachusetts General Hospital

First Received on January 29, 2009. Last Updated on July 22, 2011 History of Changes

Sponsor:	Massachusetts General Hospital
Collaborator:	Forest Laboratories
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00833469

Purpose

The purpose of this study is to determine whether women with postpartum 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.

Condition	Intervention	Phase
Postpartum Depression	Drug: Escitalopram	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Escitalopram for the Treatment of Postpartum Depression

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression Postpartum Care Postpartum Depression

Drug Information available for: Citalopram hydrobromide Citalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	November 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Escitalopram Flexible dose escitalopram 10mg	Drug: Escitalopram Once daily by mouth Other Name: Lexapro

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833469

Contacts

Contact: Stephanie D Connors, BS	617-724-6989	sdconnors@partners.org
Contact: Suzanna Fowler, BA	617-726-2912	skfowler@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Marlene P Freeman, MD 617-643-6403 mfreeman@partners.org

Sponsors and Collaborators

Massachusetts General Hospital

Forest Laboratories

Investigators

Principal Investigator:

Marlene P Freeman, MD

Massachusetts General Hospital

More Information

Additional Information:

Center for Women's Mental Health Online Resource This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Lee S. Cohen, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00833469 History of Changes
Other Study ID Numbers:	2008-P-001509
Study First Received:	January 29, 2009
Last Updated:	July 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

women
postpartum depression
anxiety

Additional relevant MeSH terms:

Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on May 24, 2012