Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients

Phase 2 Completed 133 enrolled Germans Trias i Pujol Hospital H. Lundbeck A/S · collab Hoffmann-La Roche · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to determine whether the use of an antidepressant (escitalopram) can prevent depressive episodes that appear during the treatment with peg-interferon and ribavirin in patients with chronic hepatitis C.

Timeline

Start: 2005-03
Primary completion: 2007-10
Completion: 2007-10

Outcome

Missed primary endpoint

registry Escitalopram vs Placebo; p = 0.441; Odds Ratio (OR) 0.400 (95% CI 0.075 to 2.141); Fisher Exact NCT00166296 ↗

registry Escitalopram vs Placebo; p >0.05; Chi-squared NCT00166296 ↗

Publications

Results Diez-Quevedo C, Masnou H, Planas R, Castellvi P, Gimenez D, Morillas RM, Martin-Santos R, Navines R, Sola R, Giner P, Ardevol M, Costa J, Diago M, Pretel J. Prophylactic treatment with escitalopram of pegylated interferon alfa-2a-induced depression in hepatitis C: a 12-week, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Apr;72(4):522-8. doi: 10.4088/JCP.09m05282blu. Epub 2010 Oct 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Escitalopram	Small molecule	15 mg	—