Evaluation of Neurocognitive Performance, Quality of Life, and Emotional State in Drug Substituted Patients Under Hepatitis C Therapy
Information source: University of Wuerzburg
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C Infection
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Wuerzburg Official(s) and/or principal investigator(s):
Michael Scheurlen, MD, Principal Investigator, Affiliation: Med. Klinik und Poliklinik II, University of Wuerzburg
Overall contact:
Michael Scheurlen, MD, Phone: +4993120170170, Email: scheurlen_m@klinik.uni-wuerzburg.de
Summary
Prospective, longitudinal multi-center study performed in 15 participating substitution
centers in Germany.
Aims:
- Primary objective: To compare the impact of the different substitution drugs (methadone,
buprenorphine, and suboxone) on the neurocognitive, emotional, and quality-of-life-related
tolerability in opioid dependent patients under HCV treatment.
- Secondary objective: To investigate if IFN therapy impairs efficacy (with respect to e. g.
retention rates, concomitant drug use and in particular neurocognitive function) and
tolerability of agonist maintenance treatment with methadone, buprenorphine, or suboxone
Clinical Details
Official title: Evaluation of Neurocognitive Performance, Quality of Life, and Emotional State in Drug Substituted Patients (Methadone, Buprenorphine, Suboxone) Under Hepatitis C Therapy (Peginterferon Alfa and Ribavirin)
Study design: Cohort, Prospective
Primary outcome: Time course of neurocognitive performance (as assessed by the TAP - Test Battery for Attentional Performance)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Opioid-dependent patients on current stable agonist maintenance therapy (for at least
6 months prior to study enrolment) with methadone, buprenorphine, or suboxone.
- Patients need to be infected with chronic hepatitis C and must have indication for
therapy with peginterferon alfa and ribavirin.
- Patients with informed written consent with respect to a follow-up of psychiatric side
effects and in particular neurocognitive performance.
- Patients with baseline monitoring of emotional state and neurocognitive performance.
Exclusion Criteria:
- According to SPC
- According to legal requirements reg. drug substitution therapy (BTMVV)
- Insufficient knowledge of the German language or cognitive impairment (due to the
indispensable application of questionnaires and the TAP, Test Battery of Attentional
Performance).
- Age under 18 years or over 65 years
- coinfections such as hepatitis B virus or human immunodeficiency virus
Locations and Contacts
Michael Scheurlen, MD, Phone: +4993120170170, Email: scheurlen_m@klinik.uni-wuerzburg.de
Med. Klinik und Poliklinik II, University of Wuerzburg, Wuerzburg 97070, Germany
Additional Information
Related publications: Kraus MR, Schafer A, Wissmann S, Reimer P, Scheurlen M. Neurocognitive changes in patients with hepatitis C receiving interferon alfa-2b and ribavirin. Clin Pharmacol Ther. 2005 Jan;77(1):90-100. Schäfer A, Scheurlen M, Weissbrich B, Schöttker K, Kraus MR. Sustained virological response in the antiviral therapy of chronic hepatitis C: is there a predictive value of interferon-induced depression? Chemotherapy. 2007;53(4):292-9. Epub 2007 May 10. Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Psychiatric symptoms in patients with chronic hepatitis C receiving interferon alfa-2b therapy. J Clin Psychiatry. 2003 Jun;64(6):708-14. Schäfer A, Wittchen HU, Seufert J, Kraus MR. Methodological approaches in the assessment of interferon-alfa-induced depression in patients with chronic hepatitis C - a critical review. Int J Methods Psychiatr Res. 2007;16(4):186-201. Review.
Starting date: July 2008
Ending date: December 2011
Last updated: July 7, 2008
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