Clinical trial NCT01465919: Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Depression
Keywords: depression
interferon
chronic hepatitis C
mirtazapine
Lead sponsor: Seoul National University Boramae Hospital
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks
timeFrame: Baseline and 8-week of andi-depressive treatment
Secondary outcomes:
measure: Change from baseline in quality of life at 8 weeks
timeFrame: Baseline and 8-week of andi-depressive treatment
measure: Genetic polymorphism
timeFrame: Baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: Seoul Metropolitan Government Boramae Medical Center
name: Won Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.