Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2017

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.

Interventions

  • Drug: Mirtazapine
    • Mirtazapine will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week, dosing between 7.5mg/day and 45mg/day, in patients with interferon induced depression.
  • Other: Supportive psychotherapy
    • Supportive psychotherapy will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week in patients with interferon induced depression.

Arms, Groups and Cohorts

  • Experimental: mirtazapine
    • mirtazapine
  • Other: Supportive psychotherapy
    • Supportive psychotherapy will be given by a specialized psychiatrist.

Clinical Trial Outcome Measures

Primary Measures

  • Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks
    • Time Frame: Baseline and 8-week of andi-depressive treatment
    • depression change

Secondary Measures

  • Change from baseline in quality of life at 8 weeks
    • Time Frame: 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
    • Time Frame: Baseline
    • Determination of genetic factors (single nucleotide polymorphism) as predictors of clinical responses to mirtazapine in interferon-induced depression.

Participating in This Clinical Trial

Inclusion Criteria

  • Major depressive episode diagnosed with Diagnostic and Statistical Manual Diploma in Social Medicine-IV (DSM-IV) – Hamilton Depression Scale (HAMD-17) ≥ 14 Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Boramae Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Won Kim, Professor – Seoul National University Boramae Hospital
  • Overall Official(s)
    • Won Kim, MD, PhD, Principal Investigator, Seoul Metropolitan Government Boramae Medical Center

Citations Reporting on Results

Choi JS, Kim W, Sohn BK, Lee JY, Jung HY, Oh S, Joo SK, Kim HY, Jung YJ. Association of Changes in Mood Status and Psychosocial Well-Being with Depression During Interferon-Based Treatment for Hepatitis C. Psychiatry Investig. 2017 May;14(3):314-324. doi: 10.4306/pi.2017.14.3.314. Epub 2017 May 16.

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