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. 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.