CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 162 enrolled
Drug / intervention
Sertraline +4 moredrug
Likely dose
Sertraline 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00602355
NCT00602355Phase 2Completed

Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression

Women and Infants Hospital of Rhode Island·interventional·Posted Jan 28, 2008·Updated Sep 21, 2016

In Brief

A Phase 2 clinical trial evaluating Sertraline, Placebo, and 3 other interventions for Depression, Postpartum. Completed, enrolled 162 participants across 2 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 28, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 18.4 years ago

Interventions

Sertralinedrug

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.

Placebodrug

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.

Interpersonal psychotherapy (IPT)behavioral

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.

Clinical managementbehavioral

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

Mothercraftingbehavioral

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