Therapy of interferon-induced depression in chronic hepatitis C with citalopram: a randomised, double-blind, placebo-controlled study.
BACKGROUND
Interferon-induced depression represents a major complication in antiviral treatment of chronic hepatitis C virus (HCV) infection.


OBJECTIVE
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 alpha-2b plus ribavirin), depression was monitored using the Hospital Anxiety and Depression Scale (HADS). Patients with clinically relevant interferon-induced depression (HADS >or=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.
Kraus
M R
MR
Medizinische Klinik und Poliklinik II, Department of Gastroenterology and Hepatology, Würzburg University, Klinikstr 6-8, 97070 Würzburg, Germany. kraus_m@klinik.uni-wuerzburg.de
Schäfer
A
A
Schöttker
K
K
Keicher
C
C
Weissbrich
B
B
Hofbauer
I
I
Scheurlen
M
M
D000328:Adult; D018687:Antidepressive Agents, Second-Generation / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000009:adverse effects; D015283:Citalopram / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000139:chemically induced / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D011994:Recombinant Proteins; D016896:Treatment Outcome
D018687:Antidepressive Agents, Second-Generation; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D015283:Citalopram; D011092:Polyethylene Glycols; C417083:peginterferon alfa-2b