Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01465919
Recruitment Status : Terminated (Due to the recent change in standard of care for hepatitis C.)
First Posted : November 6, 2011
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
Won Kim, Seoul National University Boramae Hospital

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Mirtazapine Other: Supportive psychotherapy Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2011
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mirtazapine
mirtazapine
Drug: Mirtazapine
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
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. Genetic polymorphism [ Time Frame: Baseline ]
    Determination of genetic factors (single nucleotide polymorphism) as predictors of clinical responses to mirtazapine in interferon-induced depression.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465919


Locations
Layout table for location information
Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of, 156-707
Sponsors and Collaborators
Seoul National University Boramae Hospital
Investigators
Layout table for investigator information
Principal Investigator: Won Kim, MD, PhD Seoul Metropolitan Government Boramae Medical Center
Publications of Results:
Layout table for additonal information
Responsible Party: Won Kim, Professor, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier: NCT01465919    
Other Study ID Numbers: 06-2011-130
First Posted: November 6, 2011    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Won Kim, Seoul National University Boramae Hospital:
depression
interferon
chronic hepatitis C
mirtazapine
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis C
Hepatitis
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Mirtazapine
Antidepressive Agents
Psychotropic Drugs
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Serotonin 5-HT2 Receptor Antagonists