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

NCT00166296 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2020-08-17

Study results available
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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.

Conditions

Interventions

DRUG

Escitalopram

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • H. Lundbeck A/S

    collaborator INDUSTRY

  • Germans Trias i Pujol Hospital

    lead OTHER

Principal Investigators

  • Crisanto Diez-Quevedo, MD · Germans Trias i Pujol University Hospital

  • Ramon Planas, MD · Germans Trias i Pujol University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00166296 on ClinicalTrials.gov