NCT00196664

Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin

Assessment of the Efficacy of Paroxetine in the Prevention of Depressive Syndrome in Patients With Chronic Hepatitis C Treated by PEG-Interferon Alfa Plus Ribavirin. Multicentric, Double-Blinded, Randomized Study. ANRS HC18 Paropeg

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Depression is a common side effect of interferon in the treatment of chronic hepatitis C. The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C.

Detailed description

The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C. This is a comparative study including two groups of patients randomly allocated : one with paroxetine and the other with the placebo. The rate of depression will be compared between the 2 groups

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Paroxetine

Timeline

• Start date: 2005-10-01
• Completion: 2009-02-01
• First posted: 2005-09-20
• Last updated: 2009-05-13

Locations

1 site across 1 country: France