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 by Massachusetts General Hospital, September 2009

First Received: January 29, 2009 Last Updated: September 25, 2009 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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study
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: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram 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:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

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

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:	Massachusetts General Hospital ( Lee S. Cohen, MD )
Study ID Numbers:	2008-P-001509
Study First Received:	January 29, 2009
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00833469 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

women
postpartum depression
anxiety

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Pregnancy Complications
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Puerperal Disorders
Depression, Postpartum
Mental Disorders
Therapeutic Uses

Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Behavioral Symptoms
Muscarinic Antagonists
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010