Paroxetine for prevention of depressive symptoms induced by interferon-alpha and ribavirin for hepatitis C

C. L. Raison, B. J. Woolwine, M. F. Demetrashvili, A. S. Borisov, R. Weinreib, J. P. Staab, J. M. Zajecka, C. J. Bruno, M. A. Henderson, J. F. Reinus, D. L. Evans, G. M. Asnis, A. H. Miller

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128 Scopus citations


Background: Whether antidepressants prevent depression during interferon-alpha/ribavirin treatment for hepatitis C virus infection has yet to be established. Aim: To investigate the use of paroxetine in a prospective, double-blind, placebo-controlled study for this indication. Methods: Sixty-one hepatitis C virus-infected patients were randomly assigned to the antidepressant, paroxetine (n = 28), or placebo (n = 33), begun 2 weeks before and continued for 24 weeks during interferon-alpha/ribavirin treatment. Primary endpoints included development of major depression and severity of depressive symptoms measured by the Montgomery Asberg Depression Rating Scale (MADRS). Results: Rates of major depression during the study were low (17%) and did not differ between groups. Nevertheless, using published MADRS cut-off scores, the percent of subjects who met criteria for mild, moderate or severe depression during interferon-alpha/ribavirin therapy was significantly lower in paroxetine- vs. placebo-treated subjects (P = 0.02, Fisher's exact test). Assignment to paroxetine was also associated with significantly reduced depressive symptom severity. This effect was largely accounted for by participants with depression scores above the median (MADRS > 3) at baseline in whom paroxetine was associated with a maximal reduction in MADRS scores of 10.3 (95% CI: 2.1-18.5) compared with placebo at 20 weeks (P < 0.01). Study limitations included a small sample size and high drop-out rate. Conclusion: This double-blind, placebo-controlled trial provides preliminary data in support of antidepressant pre-treatment in hepatitis C virus patients with elevated depressive symptoms at baseline.

Original languageEnglish (US)
Pages (from-to)1163-1174
Number of pages12
JournalAlimentary Pharmacology and Therapeutics
Issue number10
StatePublished - May 2007

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)


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