Hepatitis

Therapy of interferon-induced depression in chronic hepatitis C with citalopram: a randomised, double-blind, placebo-controlled study

M R Kraus¹, A Schäfer¹, K Schöttker¹, C Keicher¹, B Weissbrich², I Hofbauer³, M Scheurlen¹

¹ Medizinische Klinik und Poliklinik II, Department of Gastroenterology and Hepatology, University of Würzburg, Würzburg, Germany
² Institute for Virology and Immunobiology, University of Würzburg, Würzburg, Germany
³ Central Pharmacy, University of Würzburg, Würzburg, Germany

Dr M R Kraus, PhD, Medizinische Klinik und Poliklinik II, Würzburg University, Klinikstr 6–8, 97070 Würzburg, Germany; kraus_m{at}klinik.uni-wuerzburg.de

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

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

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

Results: In 28 patients (28%), HADS scores increased to >8 during interferon therapy. They were treated with placebo (n = 14) or SSRI (n = 14). HADS scores declined significantly in SSRI patients within four 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 five placebo patients as a result of intolerable depression. Rescue medication (20 mg citalopram) led to a significant decrease in HADS scores (p = 0.008). All citalopram patients were able to complete interferon therapy as planned. As 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: The findings demonstrate clearly that citalopram treatment is highly effective in HCV patients on interferon therapy, when initiated after the onset of clinically relevant depressive symptoms. This suggests that a general SSRI prophylaxis is not necessary in these patients.

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