Lexapro in the Treatment of Patients With Postpartum Depression

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00277108
First received: January 12, 2006
Last updated: November 5, 2008
Last verified: November 2008
  Purpose

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


Condition Intervention
Postpartum Depression
Drug: Escitalopram (Lexapro)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Rochester:

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

Estimated Enrollment: 20
Study Start Date: February 2004
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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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.

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  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: NCT00277108

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

No publications provided

ClinicalTrials.gov Identifier: NCT00277108     History of Changes
Other Study ID Numbers: LXP-MD80
Study First Received: January 12, 2006
Last Updated: November 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
postpartum depression
postnatal depression
PPD

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 August 01, 2014