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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Marlene P. Freeman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00833469
First received: January 29, 2009
Last updated: August 5, 2014
Last verified: August 2014

January 29, 2009
August 5, 2014
January 2009
April 2011   (final data collection date for primary outcome measure)
Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden).
Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00833469 on ClinicalTrials.gov Archive Site
  • Change in Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression.
  • Change in Beck Anxiety Inventory (BAI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety).
Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
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 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.

Not Provided
Interventional
Phase 4
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.
 
Completed
7
April 2011
April 2011   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00833469
2008-P-001509
No
Marlene P. Freeman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Forest Laboratories
Principal Investigator: Marlene P Freeman, MD Massachusetts General Hospital
Massachusetts General Hospital
August 2014

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