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Lexapro in the Treatment of Patients With Postpartum Depression

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ClinicalTrials.gov Identifier: NCT00277108
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : November 6, 2008
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
University of Rochester

Tracking Information
First Submitted Date  ICMJE January 12, 2006
First Posted Date  ICMJE January 13, 2006
Last Update Posted Date November 6, 2008
Study Start Date  ICMJE February 2004
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
The primary outcome measure will be remission of major depression, defined as a score of 12 or less on the Montgomery-Asberg Depression Scale.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00277108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2006)
A score of 7 or less on the Hamilton Depression Scale (21 item) will be used as a secondary measure of remission.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lexapro in the Treatment of Patients With Postpartum Depression
Official Title  ICMJE Open Label Variable Dose Escitalopram (Lexapro) in the Treatment of Patients With Postpartum Major Depression: A Pilot Study
Brief Summary The purpose of this study is to determine if Escitalopram (Lexapro) is effective in the treatment of postpartum depression.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Postpartum Depression
Intervention  ICMJE Drug: Escitalopram (Lexapro)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 12, 2006)
20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00277108
Other Study ID Numbers  ICMJE LXP-MD80
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Forest Laboratories
Investigators  ICMJE
Principal Investigator: Linda H Chaudron, MD, MS University of Rochester
PRS Account University of Rochester
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP