The Use of Paroxetine and Cognitive-Behavioral Therapy in Postpartum Depression and Anxiety: A Randomized Controlled Trial

Shaila Misri, M.D.; Pratibha Reebye, M.D.; Maria Corral, M.D.; and Lisa Milis, B.A.

Background: Approximately 10% to 16% of women experience a major depressive episode after childbirth. A significant proportion of these women also suffer from comorbid anxiety disorders. The purpose of this study was to evaluate whether the addition of cognitive-behavioral therapy (CBT) to standard antidepressant therapy offers additional benefits in the treatment of postpartum depression with comorbid anxiety disorders.

Method: Thirty-five women referred to a tertiary care hospital outpatient program with a DSM-IV diagnosis of postpartum depression with comorbid anxiety disorder were randomly assigned to 1 of 2 treatment groups-paroxetine-only monotherapy group (N = 16) or paroxetine plus 12 sessions of CBT combination therapy group (N = 19)-for a 12-week trial. Progress was monitored by a psychiatrist blinded to treatment group, using the Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Yale-Brown Obsessive Compulsive Scale, Clinical Global Impressions scale, and Edinburgh Postnatal Depression Scale. Data were analyzed using 2-tailed statistical tests at an alpha level of .05. The study was conducted from April 1, 2002, to June 30, 2003.

Results: Both treatment groups showed a highly significant improvement (p < .01) in mood and anxiety symptoms. Groups did not differ significantly in week of recovery, dose of paroxetine at remission, or measures of depression, anxiety, and obsessive-compulsive symptoms at outcome.

Conclusion: Antidepressant monotherapy and combination therapy with antidepressants and CBT were both efficacious in reducing depression and anxiety symptoms. However, in this sample of acutely depressed/anxious postpartum women, there were no additional benefits from combining the 2 treatment modalities. Further research into the efficacy of combination therapy in the treatment of moderate-to-severe depression with comorbid disorders in postpartum women is recommended.

(J Clin Psychiatry 2004;65:1236-1241)

Received Nov. 24, 2003; accepted March 31, 2004. From the Department of Psychiatry (Drs. Misri, Reebye, and Corral) and the Department of Obstetrics and Gynecology (Dr. Misri), Faculty of Medicine, University of British Columbia and Reproductive Mental Health Programs, St. Paul's Hospital and BC Women's Hospital and Health Centre (Drs. Misri and Corral and Ms. Milis), Vancouver, British Columbia, Canada.

GlaxoSmithKline Canada contributed funding for this study. Overall experimental design, data acquisition, statistical analyses, and interpretation of the results were implemented without any input from GlaxoSmithKline Canada.

Presented in part at the 156th Annual Meeting of the American Psychiatric Association, San Francisco, Calif., May 17-22, 2003, and at the 2nd World Congress on Women's Mental Health, Washington, D.C., March 20, 2004.

Corresponding author and reprints: Shaila Misri, M.D., Reproductive Mental Health Program, St. Paul's Hospital, 1081 Burrard Street, Vancouver, BC, Canada V6Z 1Y6 (email: smisri@providencehealth.bc.ca).