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

• Published in: Journal of affective disorders 2007-11, Vol.103 (1), p.83-90
• Main Authors: Morasco, Benjamin J, Rifai, Muhamad Aly, Loftis, Jennifer M, Indest, David W, Moles, James Kelly, Hauser, Peter
• Format: Article
• Language: English
• Subjects: Adult; Adult and adolescent clinical studies; Antidepressive Agents, Second-Generation - adverse effects; Antidepressive Agents, Second-Generation - therapeutic use; Antiviral Agents - adverse effects; Antiviral Agents - therapeutic use; Antiviral therapy; Biological and medical sciences; Depression; Depressive Disorder, Major - chemically induced; Depressive Disorder, Major - diagnosis; Depressive Disorder, Major - prevention & control; Drug Therapy, Combination; Hepatitis C; Hepatitis C - drug therapy; Human viral diseases; Humans; Infectious diseases; Interferon; Interferon-alpha - adverse effects; Interferon-alpha - therapeutic use; Male; Medical sciences; Middle Aged; Mood disorders; Neuropharmacology; Paroxetine - adverse effects; Paroxetine - therapeutic use; Personality Inventory; Pharmacology. Drug treatments; Polyethylene Glycols; Prevention; Psychiatry; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease); Psychology. Psychoanalysis. Psychiatry; Psychopathology. Psychiatry; Psychopharmacology; Recombinant Proteins; Ribavirin - adverse effects; Ribavirin - therapeutic use; Treatment Outcome; Veterans - psychology; Viral diseases; Viral hepatitis; Viral response
• ISSN: 0165-0327; 1573-2517
• DOI: 10.1016/j.jad.2007.01.007

Abstract Background Interferon-α-(IFN-α) 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-α-induced depression for the entire sample was 33.3%. The prophylactic use of paroxetine did not decrease the likelihood of IFN-α-induced depression (35.7% in the paroxetine group vs. 31.6% in the placebo group). However, in 10 of 11 patients who developed IFN-α-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-α-induced depression may not be indicated in patients with HCV infection.