Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C
- Registration Number
- NCT01465919
- Lead Sponsor
- Seoul National University Boramae Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- Major depressive episode diagnosed with Diagnostic and Statistical Manual Diploma in Social Medicine-IV (DSM-IV)
- Hamilton Depression Scale (HAMD-17) ≥ 14
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Supportive psychotherapy Supportive psychotherapy Supportive psychotherapy will be given by a specialized psychiatrist. mirtazapine Mirtazapine mirtazapine
- Primary Outcome Measures
Name Time Method Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks Baseline and 8-week of andi-depressive treatment depression change
- Secondary Outcome Measures
Name Time Method Change from baseline in quality of life at 8 weeks Baseline and 8-week of andi-depressive treatment Psychometric assessment of quality of life using The Brief Form of the World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) and Liver Disease Quality of Life (LDQOL)
Genetic polymorphism Baseline Determination of genetic factors (single nucleotide polymorphism) as predictors of clinical responses to mirtazapine in interferon-induced depression.
Trial Locations
- Locations (1)
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of