Pharmacologic treatment of postpartum women with new-onset major depressive disorder: a randomized controlled trial with paroxetine.
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.


METHODS
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.


CONCLUSIONS
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.
Yonkers
Kimberly A
KA
Department of Psychiatry, Yale University School of Medicine, New Haven, Conn, USA. Kimberly.Yonkers@yale.edu
Lin
Haiqun
H
Howell
Heather B
HB
Heath
A Christopher
AC
Cohen
Lee S
LS
D000328:Adult; D001942:Breast Feeding / Q000706:statistics & numerical data; D003710:Demography; D019052:Depression, Postpartum / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D039721:Diagnostic and Statistical Manual of Mental Disorders; D005260:Female; D006801:Humans; D017374:Paroxetine / Q000009:adverse effects / Q000627:therapeutic use*; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires
D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors