Es-Citalopram for the prevention of PEG-IFN-α and Ribavirin associated depression in HCV-infected patients without psychiatric risk factors (CIPPAD-study)

Objective: The „EsCItalopram for the Prevention of PEGASYSΘ Associated Depression study“ (CIPPAD-study) is a prospective multicentre, randomized, double-blind, placebo-controlled clinical trial with the primary objective to evaluate the impact of a 2-week antidepressant pretreatment with Escitalopram on the incidence and severity of interferon-alpha associated depression. Study design: Patients without any history of psychiatric or substance abuse disorder either received escitalopram 10mg/day 2 weeks prior to commencement of HCV therapy and or received placebo. All patients were treated with pegylated interferon-alpha-2a (PEG-IFN-α-2a) plus ribavirin. The frequency and severity of depressive episodes were defined according to DSM-IV criteria for a „major depression“ and by using the Montgomery Asperg Depression Scale (MADRS). Results: According to preliminary data from 189 patients highly significantly more patients in the placebo group (48.9%) were diagnosed from clinicians as having a major depressive episode if compared to the verum group (p<0.001). Evaluation of the severity of depressive syndromes by MADRS-scores showed that significantly more patients in the placebo group reached moderate to severe depressive symptoms during antiviral treatment (34.7%) if compared to the verum group (p=0.004). Patients in the placebo group had a 2.6 fold increased risk to reach MADRS depression scores over 15 (OR=2.57). Significantly more patients in the placebo group needed an antidepressive rescue medication with mirtazapine (p=0.004). So far no significant differences between both groups were found regarding genotype distribution and sustained virological response. Discussion: Our preliminary results clearly indicate that an antidepressive pre-treatment with escitalopram was able to significantly reduce the frequency and severity of depressive episodes during antiviral therapy with PEG-IFN-a-2a in patients without psychiatric risk factors.

Antidepressants - Antiviral treatment - Depression - Hepatitis C - Interferon-alfa - Side Effects