Therapy of interferon-induced depression in chronic hepatitis C with citalopram: a randomised, double-blind, placebo-controlled study
- 1Medizinische Klinik und Poliklinik II, Department of Gastroenterology and Hepatology, University of Würzburg, Würzburg, Germany
- 2Institute for Virology and Immunobiology, University of Würzburg, Würzburg, Germany
- 3Central Pharmacy, University of Würzburg, Würzburg, Germany
- Dr M R Kraus, PhD, Medizinische Klinik und Poliklinik II, Würzburg University, Klinikstr 6–8, 97070 Würzburg, Germany;
- Revised 19 November 2007
- Accepted 22 November 2007
- Published Online First 13 December 2007
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.
Funding: This study was supported in part by Essex Pharma (Munich, Germany), a subsidiary of Schering-Plough (Kenilworth, New Jersey, USA).
Ethics approval: Ethics approval was obtained.