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Background: Women who have suffered one episode of postpartum-onset major depression (PPMD) comprise a high-risk group for subsequent episodes. We conducted a double-blind, randomized clinical trial to test the efficacy of nortriptyline in the prevention of recurrent PPMD.
Method: Nondepressed women who had at least one past episode of PPMD (Research Diagnostic Criteria) were recruited during pregnancy. Subjects were randomly assigned to nortriptyline or placebo. Treatment began immediately postpartum. Each subject was assessed for 20 sequential weeks with the Hamilton Rating Scale for Depression and Research Diagnostic Criteria for recurrence of major depression.
Results: No difference was found in the rate of recurrence in women treated with nortriptyline compared with those treated with placebo. Of 26 subjects who took nortriptyline preventively, 6 (0.23, 95% exact confidence interval [CI] = 0.09 to 0.44) suffered recurrences. Of 25 subjects who took placebo, 6 (0.24, 95% exact CI = 0.09 to 0.45) suffered recurrence (Fisher exact p = 1.00).
Conclusion: Nortriptyline did not confer additional preventive efficacy beyond that of placebo. The rate of recurrence of PPMD (one fourth of women) was unacceptably high.
(J Clin Psychiatry 2001;62:82-86)
Received April 18, 2000; accepted Sept. 6, 2000. From the Departments of Reproductive Biology (Dr. Wisner) and Psychiatry (Drs. Wisner, Peindl, and Rapport) and the Division of Child Psychiatry (Dr. Findling), Case Western Reserve University School of Medicine, Cleveland, Ohio; the Departments of Psychiatry and Pharmacology, Western Psychiatric Institute and Clinic, University of Pittsburgh Medical Center (Dr. Perel); and the Department of Medicine, University of Pittsburgh School of Medicine (Dr. Hanusa), Pittsburgh, Pa.
Supported by National Institute of Mental Health (NIMH) grants #57102 and #60335 to Drs. Wisner and Perel. Also supported by the Clinical Pharmacology Core (NIMH grant MH-30915) for the analyses of serum nortriptyline levels in Dr. Perel's laboratory.
Presented at the 152nd annual meeting of the American Psychiatric Association, Washington, D.C., May 18, 1999.
Financial disclosure: Dr. Wisner has received honoraria from Pfizer and Solvay.
Reprint requests to: Katherine L. Wisner, M.D., M.S., Departments of Psychiatry and Reproductive Biology, Case Western Reserve University School of Medicine, 11400 Euclid Ave., Suite 280, Cleveland, OH 44106 (e-mail: klw6@po.cwru.edu).