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
  Purpose

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.


Condition Intervention Phase
Postpartum Depression
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: 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:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 7
Study Start Date: January 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833469

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Forest Laboratories
Investigators
Principal Investigator: Marlene P Freeman, MD Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Marlene P. Freeman, MD, Clinical Director, Center for Women's Mental Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00833469     History of Changes
Other Study ID Numbers: 2008-P-001509
Study First Received: January 29, 2009
Results First Received: July 11, 2014
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
women
postpartum depression
anxiety

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
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
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 16, 2014