Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline
Condition: Postpartum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional

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.
    


Intervention name(s): Sertraline; placebo; psychotherapy
Intervention type(s): Drug; Drug; Other
Intervention description(s): 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; psychotherapy
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: severity of depression measured by MADRS and CGI