Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression

NCT00602355 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2016-09-21

Study results available
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Summary

This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.

Conditions

  • Depression, Postpartum

Interventions

DRUG

Sertraline

Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.

DRUG

Placebo

Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline.

BEHAVIORAL

Interpersonal psychotherapy (IPT)

IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills.

BEHAVIORAL

Clinical management

Clinical management includes treatment as usual for those receiving medication for depression.

BEHAVIORAL

Mothercrafting

Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Women and Infants Hospital of Rhode Island

    lead OTHER

Principal Investigators

  • Caron Zlotnick · Women and Infants Hospital

  • Scott Stuart, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00602355 on ClinicalTrials.gov