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

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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Abbreviations

5α-DHP:

5α-dihydroprogesterone

ALLO:

allopregnanolone

CBT:

cognitive behavioral therapy

CGI:

Clinical Global Impressions

CNS:

central nervous system

DSM:

Diagnostic and Statistical Manual of Mental Disorders

FET:

Fisher exact tests

HAM-A:

Hamilton Anxiety Rating Scale

HAM-D:

Hamilton Depression Rating Scale

IPT:

interpersonal therapy

ITT:

intent-to-treat

H-MRS:

proton magnetic resonance spectroscopy

EPDS:

Edinburgh Postnatal Depression Scale

MDD:

major depressive disorder

PMD:

postpartum major depression

RCT:

randomized clinical trial

SCID:

Structured Clinical Interview for DSM

SERT:

serotonin transporter

SSRI:

selective serotonin reuptake inhibitor

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Acknowledgments

The conduct and analysis of this research as well as manuscript preparation was funded in part by the following entities: Pfizer (New York, NY, USA), the National Institute of Mental Health (P50 MH099910 (CNE, LH, and KC) and K23 MH01830 (CNE)), and the National Institute of Drug Abuse (K24 DA03031 (CNE)).

Conflict of interest

Dr. Epperson has received research grant support from Pfizer, Eli Lilly, Shire, and Novartis, and honoraria from Pfizer, Eli Lilly, and GlaxoSmithKline. 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.

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Correspondence to Liisa Hantsoo.

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Hantsoo, L., Ward-O’Brien, D., Czarkowski, K.A. et al. A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression. Psychopharmacology 231, 939–948 (2014). https://doi.org/10.1007/s00213-013-3316-1

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  • DOI: https://doi.org/10.1007/s00213-013-3316-1

Keywords

  • Postpartum
  • Puerperal
  • Depression
  • Sertraline
  • SSRI
  • Pregnancy
  • Women