Phase 4 Open-labeled Study to Compare the Anti-depressive Efficacy Between Mirtazapine and Psychotherapy for Patients With Interferon-related Depression During Antiviral Therapy for Hepatitis C
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks
研究概览
简要总结
The purpose of this study is to evaluate the anti-depressive efficacy of mirtazapine in depression induced by peginterferon alpha-2a and ribavirin treatment in Korean patients with chronic hepatitis C.
详细描述
Depression is a common serious adverse event (30%-50%) during the interferon treatment for chronic hepatitis C. Adequate control of depressive symptoms might enable to adhere to antiviral therapy and lead to the favorable prognosis for patients with chronic hepatitis C.
Mirtazapine is an effective antidepressant for depressive mood as well as insomnia and anxiety. Mirtazapine has also relatively lower drug-drug interactions, which are important for patients with hepatic dysfunction.
In this study, the investigators are going to perform an 8-week, randomized, open label trial comparing anti-depressive efficacy between mirtazapine and supportive psychotherapy in depression induced by peginterferon alpha-2a and ribavirin treatment in Korean patients with chronic hepatitis C.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive episode diagnosed with Diagnostic and Statistical Manual Diploma in Social Medicine-IV (DSM-IV)
- •Hamilton Depression Scale (HAMD-17) ≥ 14
排除标准
- •Any other axis I primary diagnoses except major depressive disorder
- •Having serious adverse events or hypersensitivity to mirtazapine
- •Having major depressive disorder prior to the first injection of interferon
研究组 & 干预措施
mirtazapine
mirtazapine
干预措施: Mirtazapine (Drug)
Supportive psychotherapy
Supportive psychotherapy will be given by a specialized psychiatrist.
干预措施: Supportive psychotherapy (Other)
结局指标
主要结局
Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks
时间窗: Baseline and 8-week of andi-depressive treatment
depression change
次要结局
- Change from baseline in quality of life at 8 weeks(Baseline and 8-week of andi-depressive treatment)
- Genetic polymorphism(Baseline)
研究者
Won Kim
Professor
Seoul National University Boramae Hospital