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

This study is currently recruiting participants.
Verified July 2011 by Massachusetts General Hospital
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833469
First received: January 29, 2009
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  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:

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, Postpartum
Depression
Depressive Disorder
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 23, 2013