Status:

TERMINATED

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

Lead Sponsor:

Seoul National University Boramae Hospital

Conditions:

Depression

Eligibility:

All Genders

20-75 years

Phase:

PHASE4

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2018

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT01465919

Start Date

August 1 2011

End Date

March 1 2018

Last Update

March 20 2020

Active Locations (1)

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1

SMG-SNU Boramae Medical Center

Seoul, South Korea, 156-707