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?
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.
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.
Supportive psychotherapySupportive psychotherapy will be given by a specialized psychiatrist.
Start Date: August 2011
Completed Date: June 2018
Phase: Phase 4
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