A randomized trial of paroxetine to prevent interferon-alpha-induced depression in patients with hepatitis C

J Affect Disord. 2007 Nov;103(1-3):83-90. doi: 10.1016/j.jad.2007.01.007. Epub 2007 Feb 9.


Background: Interferon-alpha-(IFN-alpha) induced depression presents a challenge when treating patients with the hepatitis C virus (HCV). Depression occurs in approximately one-third of patients during antiviral therapy and can lead to reduction in treatment dosage or discontinuation of treatment, thus reducing the likelihood of clearing HCV infection. This study examined the efficacy of paroxetine in preventing the development of depression during antiviral therapy.

Methods: In a double-blind, placebo-controlled study, 33 patients with HCV were randomly assigned to paroxetine or placebo prior to antiviral therapy. Patients were evaluated for psychiatric symptoms prior, during, and six months after antiviral therapy.

Results: The rate of IFN-alpha-induced depression for the entire sample was 33.3%. The prophylactic use of paroxetine did not decrease the likelihood of IFN-alpha-induced depression (35.7% in the paroxetine group vs. 31.6% in the placebo group). However, in 10 of 11 patients who developed IFN-alpha-induced depression and entered the rescue arm of the study, open-label treatment with paroxetine helped reduce symptoms of depression. Group assignment did not appear to impact antiviral therapy completion rates, as a similar proportion of patients from each group completed treatment.

Limitations: The antiviral treatment was changed during the trial and aspects of the sample limit the generalizability of the results.

Conclusion: A prophylactic approach to interferon-alpha-induced depression may not be indicated in patients with HCV infection.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antidepressive Agents, Second-Generation / adverse effects
  • Antidepressive Agents, Second-Generation / therapeutic use*
  • Antiviral Agents / adverse effects*
  • Antiviral Agents / therapeutic use
  • Depressive Disorder, Major / chemically induced*
  • Depressive Disorder, Major / diagnosis
  • Depressive Disorder, Major / prevention & control*
  • Drug Therapy, Combination
  • Hepatitis C / drug therapy*
  • Humans
  • Interferon alpha-2
  • Interferon-alpha / adverse effects*
  • Interferon-alpha / therapeutic use
  • Male
  • Middle Aged
  • Paroxetine / adverse effects
  • Paroxetine / therapeutic use*
  • Personality Inventory
  • Polyethylene Glycols
  • Recombinant Proteins
  • Ribavirin / adverse effects
  • Ribavirin / therapeutic use
  • Treatment Outcome
  • Veterans / psychology*


  • Antidepressive Agents, Second-Generation
  • Antiviral Agents
  • Interferon alpha-2
  • Interferon-alpha
  • Recombinant Proteins
  • Polyethylene Glycols
  • Paroxetine
  • Ribavirin
  • peginterferon alfa-2b