Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline
Status:
Completed
Trial end date:
2011-01-01
Target enrollment:
Participant gender:
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.