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Sertraline for the Prevention of Recurrent Postpartum Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Katherine Wisner, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00276900
First received: January 11, 2006
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

This study will determine the effectiveness of taking sertraline within 24 hours of giving birth in preventing a recurrence of postpartum depression.


Condition Intervention Phase
Depression
Drug: Sertraline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Prevention of Recurrent Postpartum Depression

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Depressive symptoms (measured at Weeks 24 and 52 postpartum)

Secondary Outcome Measures:
  • Functioning (measured at Weeks 24 and 52 postpartum)

Estimated Enrollment: 300
Study Start Date: December 2003
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Depression after pregnancy is called postpartum depression and may be caused by a rapid change in hormone levels during and immediately after pregnancy. Researchers believe that it is one of the most common complications linked to pregnancy. This type of depression occurs in 10 to 15% of women within the first 3 months of giving birth and it can negatively affect both mothers and their children. Mothers with postpartum depression may experience low energy, difficulty concentrating, irritability, and inability to meet their children's needs for love and affection. Research shows that children of mothers with postpartum depression may have delays in language development, difficulty with emotional bonding to others, behavioral problems, lower activity levels, sleep problems, and distress. Many women who have suffered from postpartum depression in the past are worried about a repeat episode with the birth of their next baby. This study will determine the effectiveness of taking sertraline within 24 hours of giving birth in preventing a recurrence of postpartum depression.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • 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

  • Current major depression
  • 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)
  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: NCT00276900

Locations
United States, Pennsylvania
Women's Behavioral HealthCare Program
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Katherine L. Wisner, MD Department of Psychiatry, University of Pittsburgh Medical Center
  More Information

No publications provided

Responsible Party: Katherine Wisner, Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00276900     History of Changes
Other Study ID Numbers: R01 MH53735, R01MH053735, DSIR 83-ATP
Study First Received: January 11, 2006
Last Updated: September 30, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
Postpartum Depression
Recurrent Depression

Additional relevant MeSH terms:
Depression
Depression, Postpartum
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pregnancy Complications
Puerperal Disorders
Sertraline
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014