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Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment

NCT00133276 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-02-19

No results posted yet for this study

Summary

The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but is hampered by peginterferon-induced psychopathology.

Prevention of peginterferon-induced psychopathology with selective serotonin reuptake inhibitors (SSRI's) (paroxetine) has been shown to be effective in patients treated with interferon for malignant disease. The aim is to study the effects of prophylactic treatment with escitalopram (another SSRI) on peginterferon-associated psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis C.

Conditions

  • Hepatitis C

Interventions

DRUG

Escitalopram

OD 5mg for 2 weeks; OD 10mg for 24 weeks; OD 5mg for 2 weeks

OTHER

Placebo

Sponsors & Collaborators

  • Foundation for Liver Research

    lead OTHER

Principal Investigators

  • Robert J De Knegt, MD · Erasmus MC University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-06-30
Completion
2009-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00133276 on ClinicalTrials.gov