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

Depression Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01465919
• Other study ID #: 06-2011-130
• Status: Terminated
• Phase: Phase 4
• Start date: August 2011
• Est. completion date: March 2018

Study information

• Verified date: March 2020
• Source: Seoul National University Boramae Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Hepatitis
• Hepatitis C

Intervention

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:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Boramae Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Hamilton Depression Rating Scale (HAMD)-17 at 8 weeks	depression change	Baseline and 8-week of andi-depressive treatment
Secondary	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)	Baseline and 8-week of andi-depressive treatment
Secondary	Genetic polymorphism	Determination of genetic factors (single nucleotide polymorphism) as predictors of clinical responses to mirtazapine in interferon-induced depression.	Baseline