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

Seoul National University Boramae Hospital

Status and phase: Terminated; Phase 4

Conditions: Depression

Treatments: Other: Supportive psychotherapy; Drug: Mirtazapine

Study type: Interventional

Funder types: Other

Identifiers

NCT01465919

06-2011-130

Details and patient eligibility

About

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 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.

Enrollment: 5 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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5 participants in 2 patient groups

mirtazapine

Experimental group

Description:

mirtazapine

Treatment:

Drug: Mirtazapine

Supportive psychotherapy

Other group

Description:

Supportive psychotherapy will be given by a specialized psychiatrist.

Treatment:

Other: Supportive psychotherapy