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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Incidence of depression based on MINI International Neuropsychiatric Interview (MINI, DSM IV)from D0 to W74
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Chronic hepatitis C which should be treated by PEG-interferon alfa and ribavirin with no contra-indication to anti-viral treatment
排除标准
- •Allergy to paroxetine
- •Current antidepressant treatment
- •Depression diagnosed by the MINI International Neuropsychiatric Interview (MINI, DSM IV)
- •History of bipolar syndrome
- •History of psychotic syndrome
- •Treatment by triptan, carbamazepine, millepertuis, methadone, oral anticoagulation
- •Renal insufficiency
- •HIV infection
- •Breath feeding
- •Contra-indication to PEG-interferon and or ribavirin
结局指标
主要结局
Incidence of depression based on MINI International Neuropsychiatric Interview (MINI, DSM IV)from D0 to W74
次要结局
- Evolution of depression score (MADRS and BDI scales) to W74,Quality of life (HQL questionnaire), Fatigue, Compliance to PEG-interferon and ribavirin, Virological response at W74 ,Safety