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Pharmacologic Treatment of Postpartum Women With New-Onset Major Depressive Disorder: A Randomized Controlled Trial With Paroxetine
Kimberly A. Yonkers, M.D.; Haiqun Lin, Ph.D.; Heather B. Howell, M.S.W., L.C.S.W.; A. Christopher Heath, M.D.; and Lee S. Cohen, M.D.
Objective: Approximately 6% to 8% of postpartum women suffer from major depressive disorder (MDD), but only a few controlled trials have investigated the efficacy of pharmacologic treatments. The current study determined the relative efficacy of paroxetine compared to placebo in the treatment of acute postpartum MDD.
Method: This was an 8-week, multicenter, parallel, placebo-controlled trial of paroxetine for treatment of postpartum depression. Subjects were eligible if they had an onset of DSM-IV MDD after, but within 3 months of, delivery and had a minimum score of 16 on the 17-item Hamilton Rating Scale for Depression (HAM-D-17) at intake. Seventy women were randomly assigned to either immediate-release paroxetine or matching placebo, and 31 completed the trial. Subjects were reassessed with the HAM-D-17, the Inventory of Depressive Symptomatology-Self-Report (IDS-SR) form and the Clinical Global Impressions (CGI) scales. The study was conducted between 1997 and 2004.
Results: Both groups improved over time and did not differ significantly on the HAM-D-17 or IDS-SR at follow-up. However, greater improvement in overall mean ± SD clinical severity was found for the paroxetine (Clinical Global Impressions-Severity of Illness [CGI-S] score = 1.8 ± 1.4) compared with the control group (CGI-S score = 3.1 ± 1.4; p = .05). The paroxetine group also had a significantly higher rate of remission, compared to the placebo group (37% vs. 15%, odds ratio = 3.5, 95% CI = 1.1 to 11.5). The rate of adverse effects did not differ significantly between groups.
Conclusion: Study results were limited by lower than expected enrollment and higher than anticipated attrition. Nonetheless, paroxetine treatment was associated with a significantly higher rate of remission among women with postpartum onset of MDD.
(J Clin Psychiatry 2008;69:659-665. Online Ahead of Print March 5, 2008.)
Received July 16, 2007; accepted Sept. 27, 2007. From the Departments of Psychiatry, Epidemiology and Public Health, and Obstetrics, Gynecology, and Reproductive Sciences, Yale University School of Medicine, New Haven, Conn. (Dr. Yonkers); the Department of Epidemiology and Public Health, Division of Biostatistics, Yale University School of Medicine, New Haven, Conn. (Dr. Lin); the University of Texas Southwestern Medical Center, Dallas (Dr. Heath); the Perinatal and Reproductive Psychiatry Clinical Research Program, Massachusetts General Hospital, Boston (Dr. Cohen); and the Department of Psychiatry, Yale University School of Medicine, New Haven, Conn. (Ms. Howell).
This study was supported by a Collaborative Research Trial, Investigator-Initiated grant from GlaxoSmithKline to Drs. Yonkers and Cohen and by National Institute of Mental Health grant MH01648 to Dr. Yonkers.
Dr. Yonkers has received grant/research support from Wyeth and Eli Lilly and honoraria from Berlex. Dr. Cohen has received grant/research support from Forest, Eli Lilly, Wyeth-Ayerst, GlaxoSmithKline, AstraZeneca, and Sepracor; serves as a consultant and/or advisor to Eli Lilly, Wyeth-Ayerst, GlaxoSmithKline, Ortho-McNeil, Novartis, Janssen, and JDS; and serves on the speakers bureaus for Eli Lilly, Pfizer, GlaxoSmithKline, Wyeth-Ayerst, Forest, AstraZeneca, Janssen, and Berlex. Drs. Heath and Lin and Ms. Howell report no financial or other relationship relevant to the subject of this article.
Corresponding author and reprints: Kimberly A. Yonkers, M.D., Department of Obstetrics, Gynecology, and Reproductive Sciences, Yale School of Medicine 142 Temple St., Suite 301, New Haven, CT (e-mail: Kimberly.Yonkers@yale.edu).