Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C
|ClinicalTrials.gov Identifier: NCT01465919|
Recruitment Status : Terminated (Due to the recent change in standard of care for hepatitis C.)
First Posted : November 7, 2011
Last Update Posted : May 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Mirtazapine Other: Supportive psychotherapy||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||August 2011|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||June 2018|
Mirtazapine 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 Name: Remeron
Supportive psychotherapy will be given by a specialized psychiatrist.
Other: Supportive psychotherapy
Supportive psychotherapy will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week in patients with interferon induced depression.
Other Name: psychotherapy
- Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks [ Time Frame: Baseline and 8-week of andi-depressive treatment ]depression change
- Change from baseline in quality of life at 8 weeks [ Time Frame: Baseline and 8-week of andi-depressive treatment ]Psychometric assessment of quality of life using The Brief Form of the World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF) and Liver Disease Quality of Life (LDQOL)
- Genetic polymorphism [ Time Frame: Baseline ]Determination of genetic factors (single nucleotide polymorphism) as predictors of clinical responses to mirtazapine in interferon-induced depression.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465919
|Korea, Republic of|
|SMG-SNU Boramae Medical Center|
|Seoul, Korea, Republic of, 156-707|
|Principal Investigator:||Won Kim, MD, PhD||Seoul Metropolitan Government Boramae Medical Center|