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

Primary Purpose

Depression

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Mirtazapine
Supportive psychotherapy
Sponsored by
Seoul National University Boramae Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, interferon, chronic hepatitis C, mirtazapine

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

mirtazapine

Supportive psychotherapy

Arm Description

mirtazapine

Supportive psychotherapy will be given by a specialized psychiatrist.

Outcomes

Primary Outcome Measures

Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks
depression change

Secondary Outcome Measures

Change from baseline in quality of life at 8 weeks
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
Determination of genetic factors (single nucleotide polymorphism) as predictors of clinical responses to mirtazapine in interferon-induced depression.

Full Information

First Posted
October 31, 2011
Last Updated
March 19, 2020
Sponsor
Seoul National University Boramae Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01465919
Brief Title
Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C
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 Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Due to the recent change in standard of care for hepatitis C.
Study Start Date
August 2011 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Boramae Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
depression, interferon, chronic hepatitis C, mirtazapine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mirtazapine
Arm Type
Experimental
Arm Description
mirtazapine
Arm Title
Supportive psychotherapy
Arm Type
Other
Arm Description
Supportive psychotherapy will be given by a specialized psychiatrist.
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Other Intervention Name(s)
Remeron
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Supportive psychotherapy
Other Intervention Name(s)
psychotherapy
Intervention Description
Supportive psychotherapy will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week in patients with interferon induced depression.
Primary Outcome Measure Information:
Title
Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks
Description
depression change
Time Frame
Baseline and 8-week of andi-depressive treatment
Secondary Outcome Measure Information:
Title
Change from baseline in quality of life at 8 weeks
Description
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)
Time Frame
Baseline and 8-week of andi-depressive treatment
Title
Genetic polymorphism
Description
Determination of genetic factors (single nucleotide polymorphism) as predictors of clinical responses to mirtazapine in interferon-induced depression.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Kim, MD, PhD
Organizational Affiliation
Seoul Metropolitan Government Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
156-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28539950
Citation
Choi JS, Kim W, Sohn BK, Lee JY, Jung HY, Oh S, Joo SK, Kim HY, Jung YJ. Association of Changes in Mood Status and Psychosocial Well-Being with Depression During Interferon-Based Treatment for Hepatitis C. Psychiatry Investig. 2017 May;14(3):314-324. doi: 10.4306/pi.2017.14.3.314. Epub 2017 May 16.
Results Reference
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Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C

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