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 (HADSâ‰¥9) were randomly assigned to placebo or citalopram (SSRI, 20 mg/day).
Results:<br> In 28 patients (28%), HADS scores increased to â‰¥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.
- hepatitis C
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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.