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Therapy of interferon-induced depression in chronic hepatitis C with citalopram: A randomized, double-blind, placebo-controlled study
  1. Michael R Kraus (kraus_m{at}klinik.uni-wuerzburg.de)
  1. Medizinische Klinik und Poliklinik II, University of Wuerzburg, Germany
    1. Arne Schäfer (arne.schaefer{at}mail.uni-wuerzburg.de)
    1. Medizinische Klinik und Poliklinik II, University of Wuerzburg, Germany
      1. Katrin Schöttker (schoettker_k{at}klinik.uni-wuerzburg.de)
      1. Medizinische Klinik und Poliklinik II, University of Wuerzburg, Germany
        1. Christian Keicher (keicher_c{at}klinik.uni-wuerzburg.de)
        1. Medizinische Klinik und Poliklinik II, University of Wuerzburg, Germany
          1. Benedikt Weissbrich (weissbrich{at}vim.uni-wuerzburg.de)
          1. Institute for Virology and Immunobiology, University of Wuerzburg, Germany
            1. Ingrid Hofbauer (hofbauer_i{at}apotheke.uni-wuerzburg.de)
            1. Central Pharmacy, University of Wuerzburg, Germany
              1. Michael Scheurlen (scheurlen_m{at}klinik.uni-wuerzburg.de)
              1. Medizinische Klinik und Poliklinik II, University of Wuerzburg, Germany

                Abstract

                Background:<br> Interferon (IFN) - induced depression represents a major complication in antiviral treatment of chronic hepatitis C virus (HCV) infection.

                Aim:<br> To evaluate in a placebo-controlled study the efficacy of a selective serotonin reuptake inhibitor (SSRI) in HCV patients with antiviral therapy and IFN-associated depression.

                Methods:<br> In a randomized, double-blind, placebo-controlled study, we included 100 HCV outpatients. During interferon therapy (peginterferon alfa-2b plus ribavirin), depression was monitored using the Hospital Anxiety and Depression Scale (HADS). Patients with clinically relevant IFN-induced depression (HADS≥9) were randomly assigned to placebo or citalopram (SSRI, 20 mg/day).

                Results:<br> In 28 patients (28%), HADS scores increased to ≥9 during IFN therapy. They were treated with placebo (n=14) or SSRI (n=14). HADS scores declined significantly in SSRI patients within 4 weeks of therapy (P<0.001) but not in placebo patients. This difference between subgroups was statistically significant (P=0.032). Unblinding became necessary in 5 placebo patients due to intolerable depression. Rescue medication (20 mg citalopram) lead to a significant decrease in HADS scores (P=0.008). All citalopram patients were able to complete IFN therapy as planned. Since an interim analysis showed a significant superiority of SSRI over placebo, the study was terminated prematurely. Three patients, who became depressed afterwards, were treated in an unblinded fashion with citalopram.

                Conclusions:<br> Our findings demonstrate clearly that citalopram treatment is highly effective in HCV patients on IFN therapy, when initiated after the onset of clinically relevant depressive symptoms. We suggest that a general SSRI prophylaxis is not necessary in these patients.

                • anti-depressant
                • depression
                • hepatitis C
                • placebo-controlled
                • randomized

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                • competing interests 57/4/531

                  Competing interests: MRK is a member of the Scientific Advisory Board of Essex Pharma, a subsidiary of Schering-Plough (Kenilworth, New Jersey, USA) and has served on speakers bureaus for Schering-Plough (Kenilworth, New Jersey, USA) and Essex Pharma (Munich, Germany). The other authors have no competing interests.

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