CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 133 enrolled
Drug / intervention
Escitalopram +1 moredrug
Likely dose
Escitalopram 15 mg orally once daily for 2 weeks before and 12 weeks during interferon therapyAI-extracted
Key inclusion· 3
  • ✓Chronic hepatitis C patients initiating peginterferon alfa2a + ribavirin treatment
  • ✓Age 18–65 years
  • ✓Able to understand and complete written questionnaires
Key exclusion· 8
  • ✕Hepatic cirrhosis or carcinoma
  • ✕Leucocytes <4000/mm³ or platelets <70,000/mm³
  • ✕Hemoglobin <11 g/dL (females) or <12 g/dL (males)
  • ✕Any risk factor for hemolysis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00166296
NCT00166296Phase 2Completed
CompareCT.gov

Study of the Efficacy and Safety of Escitalopram for the Prevention of Depressive Episodes Induced by Peg-Interferon Alpha2a and Ribavirin in Chronic Hepatitis C Patients. Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Germans Trias i Pujol Hospital·interventional·Posted Sep 14, 2005·Updated Aug 17, 2020

In Brief

A Phase 2 clinical trial evaluating Escitalopram and Placebo for Major Depressive Disorder and Hepatitis C, Chronic. Completed, enrolled 133 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder, Hepatitis C, Chronic
CountriesSpain
CollaboratorsHoffmann-La Roche, H. Lundbeck A/S

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2005
Enrollment StartMar 1, 2005
Primary CompletionOct 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 20.8 years ago

Interventions

Escitalopramdrug

15 mg/day starting 2 weeks before and 12 weeks during interferon therapy

Placebodrug

Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.