Paroxetine for prevention of depressive symptoms induced by interferon-alpha and ribavirin for hepatitis C.
BACKGROUND
Whether antidepressants prevent depression during interferon-alpha/ribavirin treatment for hepatitis C virus infection has yet to be established.


OBJECTIVE
To investigate the use of paroxetine in a prospective, double-blind, placebo-controlled study for this indication.


METHODS
Sixty-one hepatitis C virus-infected patients were randomly assigned to the antidepressant, paroxetine (n = 28), or placebo (n = 33), begun 2 weeks before and continued for 24 weeks during interferon-alpha/ribavirin treatment. Primary endpoints included development of major depression and severity of depressive symptoms measured by the Montgomery Asberg Depression Rating Scale (MADRS).


RESULTS
Rates of major depression during the study were low (17%) and did not differ between groups. Nevertheless, using published MADRS cut-off scores, the percent of subjects who met criteria for mild, moderate or severe depression during interferon-alpha/ribavirin therapy was significantly lower in paroxetine- vs. placebo-treated subjects (P = 0.02, Fisher's exact test). Assignment to paroxetine was also associated with significantly reduced depressive symptom severity. This effect was largely accounted for by participants with depression scores above the median (MADRS > 3) at baseline in whom paroxetine was associated with a maximal reduction in MADRS scores of 10.3 (95% CI: 2.1-18.5) compared with placebo at 20 weeks (P < 0.01). Study limitations included a small sample size and high drop-out rate.


CONCLUSIONS
This double-blind, placebo-controlled trial provides preliminary data in support of antidepressant pre-treatment in hepatitis C virus patients with elevated depressive symptoms at baseline.
Raison
C L
CL
Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, Atlanta, GA, USA.
Woolwine
B J
BJ
Demetrashvili
M F
MF
Borisov
A S
AS
Weinreib
R
R
Staab
J P
JP
Zajecka
J M
JM
Bruno
C J
CJ
Henderson
M A
MA
Reinus
J F
JF
Evans
D L
DL
Asnis
G M
GM
Miller
A H
AH
D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000493:pharmacokinetics / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000517:prevention & control* / Q000821:virology; D004311:Double-Blind Method; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000523:psychology; D006801:Humans; D016898:Interferon-alpha / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017374:Paroxetine / Q000627:therapeutic use; D012254:Ribavirin / Q000493:pharmacokinetics / Q000627:therapeutic use*
D000998:Antiviral Agents; D016898:Interferon-alpha; D017374:Paroxetine; D012254:Ribavirin