Evaluation of Neurocognitive Performance in Drug Substituted Patients Under Hepatitis C Therapy
NCT ID: NCT00682591
Last Updated: 2009-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
190 participants
OBSERVATIONAL
2008-07-31
2011-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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University of Wuerzburg
OTHER
Responsible Party
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University of Wuerzburg, Germany
Principal Investigators
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Michael Scheurlen, MD
Role: PRINCIPAL_INVESTIGATOR
Med. Klinik und Poliklinik II, University of Wuerzburg
Locations
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Med. Klinik und Poliklinik II, University of Wuerzburg
Würzburg, , Germany
Countries
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References
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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. doi: 10.1016/j.clpt.2004.09.007.
Schafer A, Scheurlen M, Weissbrich B, Schottker 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. doi: 10.1159/000102584. 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. doi: 10.4088/jcp.v64n0614.
Schafer 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. doi: 10.1002/mpr.229.
Other Identifiers
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P05595
Identifier Type: -
Identifier Source: org_study_id
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