Sertraline for the Prevention of Recurrent Postpartum Depression
NCT ID: NCT00276900
Last Updated: 2013-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
300 participants
INTERVENTIONAL
2003-12-31
2006-08-31
Brief Summary
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Detailed Description
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Participants in this double blind study will initially report to the study site two separate times while they are pregnant. At the first visit, which will last approximately 3 hours, medical and psychiatric histories will be taken. Blood and urine samples will also be collected at this time. At the second visit, which will last approximately 1 hour, participants will be randomly assigned to receive either sertraline or placebo for the year following childbirth. All participants will then either attend 10 clinic visits, each lasting 1 hour, or receive 17 phone calls over the course of the first 28 weeks postpartum. Mood symptoms and day-to-day functioning will be assessed. If the participant's baby is being breastfed, a blood sample will also be taken from the baby at Week 4 postpartum. At Week 12 postpartum, the baby will wear an actigraph to measure his or her activity for one week. At Week 24 postpartum, participants who are not depressed will be randomly assigned to either continue on sertraline or taper to placebo over 4 weeks. Those who were originally assigned to receive placebo will continue taking placebo for the remainder of the study. Starting at Week 29 postpartum, there will be approximately one clinic visit per month for the remainder of the year. Participants' functioning, ability to interact with their children, and symptoms of depression will be assessed at these visits.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
DOUBLE
Interventions
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Sertraline
Eligibility Criteria
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Inclusion Criteria
* Presents by week 36 gestation for first two study visit interviews (interviews may be combined)
* History of DSM-IV Major Depression after the age of 15
* Score no higher than 19 on the 29-item SIGH-ADS at Week 36
* Medically healthy, as determined by a physician
Exclusion Criteria
* Urine screen positive for drugs
* Currently using other therapies for depression
* DSM-IV diagnoses of bipolar 1 or 2 disorder or any psychotic episode
* History of substance abuse within 6 months prior to study entry
* Has not received any obstetrical care
* Use of medications for medical disorders (except for treatment of stable disorders)
18 Years
45 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Katherine Wisner
Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies
Principal Investigators
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Katherine L. Wisner, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Psychiatry, University of Pittsburgh Medical Center
Locations
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Women's Behavioral HealthCare Program
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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