A randomized, placebo-controlled, double-blind trial of sertraline for postpartum depression
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
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.
- APA (2000) Diagnostic and statistical manual of mental disorders (4th ed., text revision). American Psychological Association, Washington, DCGoogle Scholar
- First MB, Spitzer RL, Gibbon M, Williams JBW (1995) Structured clinical interview for DSM-IV Axis I Disorders, patient edition (SCID-I/P v 2.0). Biometrics Research, New York State Psychiatric Institute, New YorkGoogle Scholar
- Guy W (1976) ECDEU assessment manual for psychopharmacology. US Department of Health, Education, and Welfare Public Health Service Alcohol, Drug Abuse, and Mental Health Administration, Rockville, MDGoogle Scholar
- Kaplan PS, Danko CM, Kalinka CJ, Cejka AM (2012) A developmental decline in the learning-promoting effects of infant-directed speech for infants of mothers with chronically elevated symptoms of depression. Infant Behav Dev 35:369–379. doi: 10.1016/j.infbeh.2012.02.009 PubMedCentralPubMedCrossRefGoogle Scholar
- Sharp DJ, Chew-Graham C, Tylee A, et al. (2010) A pragmatic randomised controlled trial to compare antidepressants with a community-based psychosocial intervention for the treatment of women with postnatal depression: the RESPOND trial. Health Technol Assess 14:iii–iv, ix–xi, 1–153. doi: 10.3310/hta14430
- Thase ME, Nierenberg AA, Vrijland P et al (2010) Remission with mirtazapine and selective serotonin reuptake inhibitors: a meta-analysis of individual patient data from 15 controlled trials of acute phase treatment of major depression. Int Clin Psychopharmacol 25:189–198. doi: 10.1097/YIC.0b013e328330adb2 PubMedCrossRefGoogle Scholar