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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 July 2014 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: July 31, 2014
Last verified: July 2014
  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 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 ] [ 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 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
  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: July 31, 2014
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 C
Behavioral Symptoms
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Mental Disorders
Mood Disorders
RNA Virus Infections
Virus Diseases
Interferons
Mianserin
Mirtazapine
Adrenergic Agents
Adrenergic Antagonists
Adrenergic alpha-Antagonists
Anti-Infective Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents, Tricyclic
Antineoplastic Agents
Antiviral Agents
Central Nervous System Agents
Histamine Agents
Histamine Antagonists
Histamine H1 Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 24, 2014