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Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline

NCT01028482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2011-05-10

No results posted yet for this study

Summary

Introduction:

Postpartum depression (PPD) occurs in large numbers of women (between 10 - 20%) and substantially affects both their own well-being and their offspring's mental and emotional development. Whereas PPD is a form of major depression, its etiology is probably related to a combination of biological (hereditary, hormonal etc.), and psychological factors. In practice, most women suffering from PPD do not seek treatment, or are treated with psychotherapy alone due to concerns regarding pharmacotherapy. This is despite the obvious importance of reaching a rapid remission in these women. In fact, data regarding the treatment of PPD with antidepressants is surprisingly sparse and is limited to only one blinded and placebo-controlled study (with fluoxetine) and a number of studies without a placebo arm . The reason for the paucity of double-blinded placebo-controlled studies is probably due to 3 main limiting factors: Firstly, the reluctance of women to "admit" to and seek professional help due to depression, Secondly, the difficulty to administer antidepressant medication to lactating women, and, Thirdly, the ethical difficulties in designing a study with a real placebo group.

In contrast to the very limited number of drug studies in this population, there are a number of studies that have shown the efficacy of psychotherapy in the treatment of PPD. Positive studies have been published using different types of psychotherapy, including cognitive, dynamic and interpersonal psychotherapy.

The investigators propose to study the efficacy of psychotherapeutic treatment in women suffering from PPD with add-on sertraline in a randomized double-blind, placebo-controlled design. To overcome the difficulties described above in studying antidepressants in the postpartum period, the investigators propose to include active brief dynamic psychotherapy for all women. Furthermore, the investigators will selectively allow inclusion of women who only suffer from either mild or moderate major PPD (not severe / suicidal) .

Hypothesis:

The investigators hypothesize that women with PPD randomized to the arm receiving psychotherapy + active sertraline will show a greater response rate than the psychotherapy + placebo group. Furthermore, the investigators hypothesize that the difference in response between the 2 groups will demonstrate a significant early response in the active sertraline group.

Conditions

Interventions

DRUG

Sertraline

group A- sertraline 50-100 mg/day and weekly psychotherapy for 3 months group B- weekly psychotherapy- for 3 months group C- sertraline 50-100 mg/day-for 3 months

DRUG

placebo

placebo

OTHER

psychotherapy

psychotherapy

Sponsors & Collaborators

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2010-11-30
Completion
2011-01-31

Countries

  • Israel

Study Locations

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Entities

Drugs
Diseases

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 NCT01028482 on ClinicalTrials.gov