Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C
Information source: Seoul National University Boramae Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression
Intervention: Mirtazapine (Drug); Supportive psychotherapy (Other)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Seoul National University Boramae Hospital Official(s) and/or principal investigator(s): Won Kim, MD, PhD, Principal Investigator, Affiliation: Seoul Metropolitan Government Boramae Medical Center
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.
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks
Secondary outcome: Change from baseline in quality of life at 8 weeksGenetic polymorphism
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
SMG-SNU Boramae Medical Center, Seoul 156-707, Korea, Republic of
Additional Information
Starting date: August 2011
Last updated: May 18, 2015
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