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Lexapro in the Treatment of Patients With Postpartum Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00277108
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : November 6, 2008
Forest Laboratories
Information provided by:
University of Rochester

Brief Summary:
The purpose of this study is to determine if Escitalopram (Lexapro) is effective in the treatment of postpartum depression.

Condition or disease Intervention/treatment Phase
Postpartum Depression Drug: Escitalopram (Lexapro) Not Applicable

Detailed Description:

Primary objectives: Remission of Major Depression: To determine the efficacy of a flexibly titrated dose of Escitalopram (10mg to 20 mg) in the treatment of women with postpartum depression. The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale. A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission. The null hypothesis is that flexibly dosed Escitalopram does not lead to remission of major depression based on total MADRS scores after 8 weeks of treatment.

Secondary objectives:

  1. To determine if treatment with Escitalopram is effective in achieving significant reduction in symptoms of postpartum depression as measured on several instruments: HAM-D 21, CGI, Beck Depression Inventory, Edinburgh Postnatal Depression Scale. Specifically, a response will be defined as a reduction of the total scores of 50% or more from baseline on the MADRS or HAM-D 21.
  2. To determine the tolerability, safety and some dosing considerations for Escitalopram in this special subpopulation of depressed patients. Adverse events data (clinical and laboratory), compliance and early termination will be used as outcome measures.
  3. To determine in a post-hoc analysis if pre-study anxiety levels as measured with HAM-A correlate with primary and secondary outcomes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Variable Dose Escitalopram (Lexapro) in the Treatment of Patients With Postpartum Major Depression: A Pilot Study
Study Start Date : February 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Primary Outcome Measures :
  1. The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale.

Secondary Outcome Measures :
  1. A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Biological mothers of infants ages 2 weeks to 12 months of age
  2. Age 18 and over
  3. Must understand and speak English well enough to read and provide written informed consent, complete written questionnaires and complete the SCID.
  4. The primary Axis I diagnosis, as determined by the SCID, must meet the DSM-IV criteria for Unipolar Major Depression, Single or Recurrent, Moderate to Severe. Onset of depression must occur within pregnancy to the first 12 months following childbirth. Concurrent diagnoses of anxiety disorders including obsessive compulsive disorder, panic disorder, specific phobias, generalized anxiety disorder, and post-traumatic stress disorder will be allowed if they are not the primary diagnosis.
  5. The subject must receive a MADRS total score of > 22 at screening and at the baseline visit and a total score of >17 on the HAM-D at the baseline visit.
  6. The subject must be able to comply with instructions and be capable of participating in an 8 week study.


Exclusion Criteria:

  1. Under 18 years of age.
  2. Subjects who are breastfeeding.
  3. History of Bipolar Disorder, Schizoaffective Disorder, Schizophrenia.
  4. History of any DSM-IV Axis II diagnosis, which in the investigator's opinion, would interfere with compliance of the protocol.
  5. History of alcohol or drug abuse or dependence in the last year.
  6. Treatment with other psychotropic drugs except permissible concomitants.
  7. Current severe psychiatric symptoms requiring psychiatric hospitalization, current psychosis or suicidal, homicidal potential.
  8. History of intolerance to or hypersensitivity to Citalopram.
  9. Subjects whose depressions are known to be unresponsive to Escitalopram.
  10. Subjects who are pregnant or who intend to become pregnant during the course of the study.
  11. Subjects who have any medical or neurological disorder that in the investigators' opinion may contribute to depression.
  12. Subjects who have started psychotherapy within three months prior to baseline or who intend to start psychotherapy during the study.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00277108

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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Forest Laboratories
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Principal Investigator: Linda H Chaudron, MD, MS University of Rochester

Layout table for additonal information Identifier: NCT00277108     History of Changes
Other Study ID Numbers: LXP-MD80
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: November 6, 2008
Last Verified: November 2008
Keywords provided by University of Rochester:
postpartum depression
postnatal depression
Additional relevant MeSH terms:
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Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents