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Completed

NCT Number: NCT00833469

Escitalopram (Lexapro) 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.

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Key information

Conditions

Postpartum Depression Anxiety Disorders Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

Once daily by mouth

Other names: Lexapro

Primary outcomes

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

    Time frame: 8 weeks

    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 outcomes

  1. Change in Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: 8 weeks

    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.

  2. Change in Beck Anxiety Inventory (BAI)

    Time frame: 8 weeks

    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).

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Forest Laboratories

Registry information

Official study title

Escitalopram for the Treatment of Postpartum Depression

Acronym: LexaproPPD

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 2, 2009
Registry last updated
Aug 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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