NCT01465919

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_4 depression

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_4 depression

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

6.3 years

First QC Date

October 31, 2011

Last Update Submit

March 19, 2020

Conditions

Depression

Keywords

depressioninterferonchronic hepatitis Cmirtazapine

Outcome Measures

Primary Outcomes (1)

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

    depression change

    Baseline and 8-week of andi-depressive treatment

Secondary Outcomes (2)

  • Change from baseline in quality of life at 8 weeks

    Baseline and 8-week of andi-depressive treatment

  • Genetic polymorphism

    Baseline

Study Arms (2)

mirtazapine

EXPERIMENTAL

mirtazapine

Drug: Mirtazapine

Supportive psychotherapy

OTHER

Supportive psychotherapy will be given by a specialized psychiatrist.

Other: Supportive psychotherapy

Interventions

MirtazapineDRUG

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.

Also known as: Remeron
mirtazapine
Supportive psychotherapyOTHER

Supportive psychotherapy will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week in patients with interferon induced depression.

Also known as: psychotherapy
Supportive psychotherapy

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major depressive episode diagnosed with Diagnostic and Statistical Manual Diploma in Social Medicine-IV (DSM-IV)
  • Hamilton Depression Scale (HAMD-17) ≥ 14

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 28539950RESULT

MeSH Terms

Conditions

DepressionHepatitis C, Chronic

Interventions

MirtazapinePsychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorHepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBehavioral Disciplines and Activities

Study Officials

  • Won Kim, MD, PhD

    Seoul Metropolitan Government Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 7, 2011

Study Start

August 1, 2011

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)