Gut. Published Online First: 13 December 2007. doi:10.1136/gut.2007.131607
Paper |
Therapy of interferon-induced depression in chronic hepatitis C with citalopram: A randomized, double-blind, placebo-controlled study
1 Medizinische Klinik und Poliklinik II, University of Wuerzburg, Germany
2 Institute for Virology and Immunobiology, University of Wuerzburg, Germany
3 Central Pharmacy, University of Wuerzburg, Germany
* To whom correspondence should be addressed. E-mail: kraus_m{at}klinik.uni-wuerzburg.de.
Accepted 22 November 2007
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 (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.
Keywords: anti-depressant, depression, hepatitis C, placebo-controlled, randomized
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