A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression
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Postpartum depression (PMD) occurs in roughly 10 % of postpartum women and negatively impacts the mother and her offspring, but there are few placebo-controlled studies of antidepressant treatment in this population.
The objective was this study is to compare the selective serotonin reuptake inhibitor (SSRI) sertraline to placebo for treating PMD.
This was a single-center, 6-week, randomized double-blind placebo-controlled trial of sertraline with a 1-week placebo lead-in. The participants (n = 38) were women with depression onset within 3 months of delivery; a subset (n = 27) met strict DSM-IV criteria for PMD (onset within 4 weeks of delivery). The participants were prescribed sertraline 50 mg or placebo daily to a maximum of 200 mg/day. Primary outcome variables were the Hamilton Depression Rating Scale (HAM-D) and Clinical Global Impressions (CGI) scores, which were used to determine the rates of response and remission.
Sertraline produced a significantly greater response rate (59 %) than placebo (26 %) and a more than twofold increased remission rate (53 % vs. 21 %). Mixed models did not reveal significant group by time effects, although in the subset of women who met the DSM-IV criteria, there was a statistically significant group by time effect for the HAM-D, Hamilton Anxiety Rating Scale (HAM-A), and CGI.
Women with PMD are more likely to have a remission of their depression with sertraline treatment, a finding that is more pronounced in women who have onset of depression within 4 weeks of childbirth. These data support the continued use of 4 weeks for the DSM-5 postpartum onset specifier for major depressive disorder.
KeywordsPostpartum Puerperal Depression Sertraline SSRI Pregnancy Women
cognitive behavioral therapy
Clinical Global Impressions
central nervous system
Diagnostic and Statistical Manual of Mental Disorders
Fisher exact tests
Hamilton Anxiety Rating Scale
Hamilton Depression Rating Scale
proton magnetic resonance spectroscopy
Edinburgh Postnatal Depression Scale
major depressive disorder
postpartum major depression
randomized clinical trial
Structured Clinical Interview for DSM
selective serotonin reuptake inhibitor
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