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

Primary Purpose

Postpartum Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Depression focused on measuring women, postpartum depression, anxiety

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Escitalopram

Arm Description

Flexible dose escitalopram 10mg

Outcomes

Primary Outcome Measures

Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
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).

Secondary Outcome Measures

Change in Edinburgh Postnatal Depression Scale (EPDS)
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)
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).

Full Information

First Posted
January 29, 2009
Last Updated
August 5, 2014
Sponsor
Massachusetts General Hospital
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00833469
Brief Title
Escitalopram (Lexapro) for the Treatment of Postpartum Depression
Acronym
LexaproPPD
Official Title
Escitalopram for the Treatment of Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Forest Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
Keywords
women, postpartum depression, anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Flexible dose escitalopram 10mg
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Once daily by mouth
Primary Outcome Measure Information:
Title
Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in Edinburgh Postnatal Depression Scale (EPDS)
Description
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.
Time Frame
8 weeks
Title
Change in Beck Anxiety Inventory (BAI)
Description
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).
Time Frame
8 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene P Freeman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.womensmentalhealth.org
Description
Center for Women's Mental Health Online Resource

Learn more about this trial

Escitalopram (Lexapro) for the Treatment of Postpartum Depression

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