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Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

NCT00357045 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2006-07-27

No results posted yet for this study

Summary

Objectives:

1. To determine whether paroxetine can prevent major depression in patients with hepatitis C (HCV) who are receiving pegylated-interferon (Peg-IFN).
2. To determine whether paroxetine can prevent subsyndromal increases in depression and anxiety in patients with HCV who are receiving Peg-IFN.
3. To determine whether paroxetine can prevent a significant change in the health related quality of life in patients with HCV who are receiving Peg-IFN.
4. To determine whether paroxetine improves compliance with Peg-IFN therapy for HCV.
5. To determine whether paroxetine enables patients to complete Peg-IFN therapy for HCV who might otherwise require a dose reduction or discontinuation because of neuropsychiatric side effects.

Conditions

Interventions

DRUG

Paroxetine

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Schering-Plough

    collaborator INDUSTRY

  • Portland VA Medical Center

    lead FED

Principal Investigators

  • J. K. Moles, M.D. · Salem VA Medical Center

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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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 NCT00357045 on ClinicalTrials.gov