SAN FRANCISCO — Patients with hepatitis C who were given prophylactic escitalopram in advance of therapy with peginterferon and ribavirin had one-third the incidence of major depression as did those who were given a placebo, according to a randomized, controlled trial.
Depression is a common and serious complication of interferon therapy, occurring in 20%–40% of patients, said Dr. Thomas Berg at the annual meeting of the American Association for the Study of Liver Diseases. He and his colleagues undertook a study to see if some of these cases of depression can be prevented.
According to DSM-IV criteria, 49% of the 96 patients taking placebo had major depressive episodes during 24 or 48 weeks of therapy with peginterferon α-2a, compared with just 14% of the 108 patients who took 10 mg of escitalopram daily, a significant difference.
There was no significant difference between the groups in sustained virologic response rates. About half the patients in each group achieved a sustained virologic response, said Dr. Berg of the Virchow Clinic at Charité Medical University of Berlin.
The patients began taking escitalopram or placebo 2 weeks before the start of antiviral therapy. That therapy consisted of 180 mcg per week of peginterferon α-2a and 800–1,200 mg of ribavirin per day. Patients with HCV type 2 or type 3 underwent treatment for 24 weeks, and those with type 1 or type 4 underwent treatment for 48 weeks. Investigators followed all patients for 72 weeks.
In addition to determining if patients met DSM-IV criteria for major depressive episodes, researchers administered the Montgomery-Åsberg Depression Rating Scale (MADRS), defining a score of 15 or greater on that scale as indicating significant depression. Patients underwent psychiatric evaluations at baseline and at weeks 4, 12, 24, 48, and 72.
Patients in either group who developed clinically relevant depression received open-label treatment with mirtazapine in addition to either placebo or escitalopram.
At baseline, the patients' mean age was 47 years, 52% were male, and the mean HCV RNA was over 1,000,000 IU/mL.
As judged by MADRS scores, 35% of patients taking placebo and 17% of patients taking escitalopram had moderate to severe depression during the course of therapy, a significant difference. Significant differences emerged starting at week 12 and lasting to week 48. As late as week 72 (24–48 weeks following the end of antiviral therapy), the difference in MADRS scores trended toward statistical significance (P = .051).
Dr. Berg has received research grants and served as an investigator, advisory board member, and speaker for Hoffman-La Roche Ltd. and Schering-Plough Inc. Hoffman-La Roche provided financial support for the study.