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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Boramae Hospital
Sponsor:
Information provided by (Responsible Party):
Won Kim, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier:
NCT01465919
First received: October 31, 2011
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Depression
Drug: Mirtazapine
Other: Supportive psychotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Boramae Hospital:

Primary Outcome Measures:
  • Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks [ Time Frame: Baseline and 8-week of andi-depressive treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in quality of life at 8 weeks [ Time Frame: Baseline and 8-week of andi-depressive treatment ] [ Designated as safety issue: No ]
    Psychometric assessment of quality of life using WHOQOL-BREF and LDQOL

  • Genetic polymorphism [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Determination of genetic factors (single nucleotide polymorphism) as predictors of clinical responses to mirtazapine in interferon-induced depression.


Estimated Enrollment: 56
Study Start Date: August 2011
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major depressive episode diagnosed with DSM-IV
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465919

Contacts
Contact: Won Kim, MD, PhD 82-2-870-2233 wonshiri@yahoo.com
Contact: Young Jung Moon, RN, CRA 82-2-870-2857 god3718@hanmail.net

Locations
Korea, Republic of
SMG-SNU Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 156-707
Sub-Investigator: Jung-Seok Choi, MD, PhD         
Sub-Investigator: Hee Yeon Jung, MD, PhD         
Sponsors and Collaborators
Seoul National University Boramae Hospital
Investigators
Principal Investigator: Won Kim, MD, PhD Seoul Metropolitan Government Boramae Medical Center
  More Information

No publications provided

Responsible Party: Won Kim, Professor, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier: NCT01465919     History of Changes
Other Study ID Numbers: 06-2011-130
Study First Received: October 31, 2011
Last Updated: December 2, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Boramae Hospital:
depression
interferon
chronic hepatitis C
mirtazapine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Hepatitis
Hepatitis A
Hepatitis C
Behavioral Symptoms
Mood Disorders
Mental Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Interferons
Mirtazapine
Mianserin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Histamine H1 Antagonists
Histamine Antagonists

ClinicalTrials.gov processed this record on July 24, 2014