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, Jeffrey P Staab, J. M. Zajecka, C. J. Bruno, M. A. Henderson, J. F. Reinus, D. L. Evans, G. M. Asnis, A. H. Miller

Research output: Contribution to journalArticle

117 Citations (Scopus)

Abstract

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
Volume25
Issue number10
DOIs
StatePublished - May 2007
Externally publishedYes

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Paroxetine
Ribavirin
Hepatitis C
Interferon-alpha
Depression
Placebos
Hepacivirus
Antidepressive Agents
Virus Diseases
Therapeutics
Sample Size

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Paroxetine for prevention of depressive symptoms induced by interferon-alpha and ribavirin for hepatitis C. / Raison, C. L.; Woolwine, B. J.; Demetrashvili, M. F.; Borisov, A. S.; Weinreib, R.; Staab, Jeffrey P; Zajecka, J. M.; Bruno, C. J.; Henderson, M. A.; Reinus, J. F.; Evans, D. L.; Asnis, G. M.; Miller, A. H.

In: Alimentary Pharmacology and Therapeutics, Vol. 25, No. 10, 05.2007, p. 1163-1174.

Research output: Contribution to journalArticle

Raison, CL, Woolwine, BJ, Demetrashvili, MF, Borisov, AS, Weinreib, R, Staab, JP, Zajecka, JM, Bruno, CJ, Henderson, MA, Reinus, JF, Evans, DL, Asnis, GM & Miller, AH 2007, 'Paroxetine for prevention of depressive symptoms induced by interferon-alpha and ribavirin for hepatitis C', Alimentary Pharmacology and Therapeutics, vol. 25, no. 10, pp. 1163-1174. https://doi.org/10.1111/j.1365-2036.2007.03316.x
Raison, C. L. ; Woolwine, B. J. ; Demetrashvili, M. F. ; Borisov, A. S. ; Weinreib, R. ; Staab, Jeffrey P ; Zajecka, J. M. ; Bruno, C. J. ; Henderson, M. A. ; Reinus, J. F. ; Evans, D. L. ; Asnis, G. M. ; Miller, A. H. / Paroxetine for prevention of depressive symptoms induced by interferon-alpha and ribavirin for hepatitis C. In: Alimentary Pharmacology and Therapeutics. 2007 ; Vol. 25, No. 10. pp. 1163-1174.
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abstract = "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.",
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T1 - Paroxetine for prevention of depressive symptoms induced by interferon-alpha and ribavirin for hepatitis C

AU - Raison, C. L.

AU - Woolwine, B. J.

AU - Demetrashvili, M. F.

AU - Borisov, A. S.

AU - Weinreib, R.

AU - Staab, Jeffrey P

AU - Zajecka, J. M.

AU - Bruno, C. J.

AU - Henderson, M. A.

AU - Reinus, J. F.

AU - Evans, D. L.

AU - Asnis, G. M.

AU - Miller, A. H.

PY - 2007/5

Y1 - 2007/5

N2 - 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.

AB - 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.

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