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

Depression research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Depression

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:MirtazapineMirtazapine 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 psychotherapySupportive psychotherapy will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week in patients with interferon induced depression.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

mirtazapinemirtazapine

Supportive psychotherapySupportive psychotherapy will be given by a specialized psychiatrist.

Study Status

Terminated

Start Date: August 2011

Completed Date: June 2018

Phase: Phase 4

Type: Interventional

Design:

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 weeks

Study sponsors, principal investigator, and references

Principal Investigator: Won Kim, MD, PhD

Lead Sponsor: Seoul National University Boramae Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01465919

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