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Completed

NCT Number: NCT01028482

Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women 18- 45 y.o.
  • SCID-DSM-IV diagnosis of major depression, mild to moderate severity
  • Understanding of Hebrew
  • Willing to sign the informed consent
  • Lactating women will be included after a thorough explanation of current knowledge of sertraline and lactation.

Exclusion criteria

  • Severe major depression (MADRS > 30)
  • Suicidal ideation (MADRS item 10 score of > 5)
  • Psychotic symptoms or aggressive thoughts toward the baby.
  • Current treatment with antidepressant medication
  • Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
  • Alcoholism or drug abuse and dependence
  • Bipolar Disorder
  • Past severe side effects to SSRIs

Treatment and study plan

Sertraline

Drug

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

Placebo

Drug

placebo

Psychotherapy

Other

psychotherapy

Primary outcomes

  1. depression

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Dec 9, 2009
Registry last updated
May 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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