NCT00276900

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_3 depression

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

October 7, 2013

Status Verified

September 1, 2013

Enrollment Period

2.7 years

First QC Date

January 11, 2006

Last Update Submit

September 30, 2013

Conditions

Depression

Keywords

Postpartum DepressionRecurrent Depression

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms (measured at Weeks 24 and 52 postpartum)

Secondary Outcomes (1)

  • Functioning (measured at Weeks 24 and 52 postpartum)

Interventions

SertralineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's Behavioral HealthCare Program

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

DepressionDepression, Postpartum

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Katherine L. Wisner, MD

    Department of Psychiatry, University of Pittsburgh Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies

Study Record Dates

First Submitted

January 11, 2006

First Posted

January 13, 2006

Study Start

December 1, 2003

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

October 7, 2013

Record last verified: 2013-09

Locations

US(1)