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Randomized Controlled Trial
. 2014 Mar;231(5):939-48.
doi: 10.1007/s00213-013-3316-1. Epub 2013 Oct 31.

A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression

Liisa Hantsoo  1 , Deborah Ward-O'Brien, Kathryn A Czarkowski, Ralitza Gueorguieva, Lawrence H Price, C Neill Epperson
Affiliations
Randomized Controlled Trial

A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression

Liisa Hantsoo et al. Psychopharmacology (Berl). 2014 Mar.

Abstract

Rationale: 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.

Objective: The objective was this study is to compare the selective serotonin reuptake inhibitor (SSRI) sertraline to placebo for treating PMD.

Methods: 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.

Results: 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.

Conclusions: 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.

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Conflict of interest statement

Conflicts of Interest: Dr. Epperson has received research grant support from Pfizer, Eli Lilly, Shire, and Novartis, and honoraria from Pfizer, Eli Lilly, and Glaxo Smith Kline. Dr. Epperson or a family member holds stock in Johnson and Johnson, Pfizer, Merck and Company, Abbvie, and Abbott. Dr. Price has received research support from Medtronic, Neuronetics, NIH, HRSA, and Neosync; he has served on advisory panels for Abbott and AstraZeneca; and he has served as a consultant to Gerson Lehrman, Wiley, Springer, Qatar National Research Fund, and Abbott. All other authors declare that they have no conflicts of interest.

Figures

FIGURE 1
FIGURE 1. RESPONDERS BY TREATMENT GROUP
Response rates in intent to treat (ITT) and evaluable samples, by treatment group, represented as percentage. In the evaluable group, there was a significantly greater number of responders among those women randomized to sertraline (67%, 10/15) compared to those in the placebo group (28%, 5/18), (χ2 (1)=4.99, p=0.03). In the ITT group, there was a significantly greater number of responders among those women randomized to sertraline (59%, 10/17) vs. those randomized to placebo (26%, 5/19), (χ2 (1)=3.9, p=0.05).
FIGURE 2
FIGURE 2. HAM-D Score by Week
Mean HAM-D score with standard error from Baseline through study completion among evaluable subjects. 2a: In the full evaluable sample, there was no significant group x time effect (F(1,145)=1.95, p=0.17). Mean HAM-D scores at EOL were 21.9 (sertraline) and 22.3 (placebo) and at EOW6 were 8.8 (sertraline) and 13.0 (placebo). 2b: Among evaluable subjects meeting DSM-IV criteria for PMD, there was a statistically significant group x time effect (F(1,104)=6.87, p=0.01). Mean HAM-D scores at EOL were 22.1 (sertraline) and 22.9 (placebo) and at EOW6 were 8.0 (sertraline) and 15.8 (placebo). HAM-D - Hamilton Depression Rating Scale, EOL – End of Placebo Lead-In, EOW – End of Week, PMD – Postpartum Major Depression. Significant group differences by time point at two-sided 0.05 significance level are denoted by *.
FIGURE 3
FIGURE 3. CONSORT Flow Diagram
CONSORT diagram depicting participant flow through the study.
See this image and copyright information in PMC

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