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

Abstract

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.

• Authors: Kimberly A Yonkers, Haiqun Lin, Heather B Howell, A Christopher Heath, Lee S Cohen
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 69 Issue 4 Pg. 659-65 (Apr 2008) ISSN: 1555-2101 [Electronic] United States
• PMID: 18363420 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)

Chemical References

• Serotonin Uptake Inhibitors
• Paroxetine

Topics

• Adult
• Breast Feeding (statistics & numerical data)
• Demography
• Depression, Postpartum (diagnosis, drug therapy, psychology)
• Depressive Disorder, Major (diagnosis, drug therapy, psychology)
• Diagnostic and Statistical Manual of Mental Disorders
• Female
• Humans
• Paroxetine (adverse effects, therapeutic use)
• Selective Serotonin Reuptake Inhibitors (adverse effects, therapeutic use)
• Surveys and Questionnaires