Sertraline in Depression - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Depression

Intervention / Treatment

Drug: Sertraline

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.

Study Type

Interventional

Enrollment

300

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
    - Women's Behavioral HealthCare Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Factorial Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Depressive symptoms (measured at Weeks 24 and 52 postpartum)

Secondary Outcome Measures

Outcome Measure
Functioning (measured at Weeks 24 and 52 postpartum)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: Katherine L. Wisner, MD, Department of Psychiatry, University of Pittsburgh Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

August 1, 2006

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

January 11, 2006

First Submitted That Met QC Criteria