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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

January 29, 2009
July 22, 2011
January 2009
November 2010   (final data collection date for primary outcome measure)
Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00833469 on ClinicalTrials.gov Archive Site
Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Escitalopram (Lexapro) for the Treatment of Postpartum Depression
Escitalopram for the Treatment of Postpartum Depression

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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Postpartum Depression
Drug: Escitalopram
Once daily by mouth
Other Name: Lexapro
Experimental: Escitalopram
Flexible dose escitalopram 10mg
Intervention: Drug: Escitalopram
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
November 2011
November 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
No
Contact: Stephanie D Connors, BS 617-724-6989 sdconnors@partners.org
Contact: Suzanna Fowler, BA 617-726-2912 skfowler@partners.org
United States
 
NCT00833469
2008-P-001509
No
Lee S. Cohen, MD, Massachusetts General Hospital
Massachusetts General Hospital
Forest Laboratories
Principal Investigator: Marlene P Freeman, MD Massachusetts General Hospital
Massachusetts General Hospital
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP