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Sertraline for the Prevention of Recurrent Postpartum Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Sertraline
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Postpartum Depression, Recurrent Depression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Women's Behavioral HealthCare Program

Outcomes

Primary Outcome Measures

Depressive symptoms (measured at Weeks 24 and 52 postpartum)

Secondary Outcome Measures

Functioning (measured at Weeks 24 and 52 postpartum)

Full Information

First Posted
January 11, 2006
Last Updated
September 30, 2013
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00276900
Brief Title
Sertraline for the Prevention of Recurrent Postpartum Depression
Official Title
Prevention of Recurrent Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Postpartum Depression, Recurrent Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sertraline
Primary Outcome Measure Information:
Title
Depressive symptoms (measured at Weeks 24 and 52 postpartum)
Secondary Outcome Measure Information:
Title
Functioning (measured at Weeks 24 and 52 postpartum)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L. Wisner, MD
Organizational Affiliation
Department of Psychiatry, University of Pittsburgh Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Behavioral HealthCare Program
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Sertraline for the Prevention of Recurrent Postpartum Depression

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