Status:
COMPLETED
Lexapro in the Treatment of Patients With Postpartum Depression
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Forest Laboratories
Conditions:
Postpartum Depression
Eligibility:
FEMALE
18+ years
Phase:
NA
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 prima...
Eligibility Criteria
Inclusion
- Biological mothers of infants ages 2 weeks to 12 months of age
- Age 18 and over
- Must understand and speak English well enough to read and provide written informed consent, complete written questionnaires and complete the SCID.
- 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.
- 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.
- The subject must be able to comply with instructions and be capable of participating in an 8 week study.
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Exclusion
- Under 18 years of age.
- Subjects who are breastfeeding.
- History of Bipolar Disorder, Schizoaffective Disorder, Schizophrenia.
- History of any DSM-IV Axis II diagnosis, which in the investigator's opinion, would interfere with compliance of the protocol.
- History of alcohol or drug abuse or dependence in the last year.
- Treatment with other psychotropic drugs except permissible concomitants.
- Current severe psychiatric symptoms requiring psychiatric hospitalization, current psychosis or suicidal, homicidal potential.
- History of intolerance to or hypersensitivity to Citalopram.
- Subjects whose depressions are known to be unresponsive to Escitalopram.
- Subjects who are pregnant or who intend to become pregnant during the course of the study.
- Subjects who have any medical or neurological disorder that in the investigators' opinion may contribute to depression.
- Subjects who have started psychotherapy within three months prior to baseline or who intend to start psychotherapy during the study.
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Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00277108
Start Date
February 1 2004
End Date
April 1 2007
Last Update
November 6 2008
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642