Long-Term Evaluation Follow-up of Neurocognitive Performance and Emotional State in Patients With Chronic Hepatitis C

NCT00227149 | Completed

• 1 other identifier: PO 4406
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

This is a long-term evaluation follow-up study of neurocognitive performance and emotional state in patients with chronic hepatitis C infection and a former (peg)interferon alfa-2b-based therapy. M.R. Kraus, G. Teuber, NN, NN (MPsych), M. Scheurlen Questions:

• Neurocognitive and psychiatric changes induced by interferon alfa-2b therapy in patients with chronic hepatitis C - are they fully reversible in long-term follow-up after the end of antiviral treatment?
• At least 12 months after the end of antiviral treatment - are neurocognitive and mood-related parameters even significantly improved as compared to pretreatment values? Is this possibly only true of patients with successful virus eradication?
• At least 12 months after the end of antiviral treatment, is there a significant difference between patients with and without sustained virological response with respect to neurocognitive performance, emotional state and quality of life?
• In the absence of clinically significant liver damage in patients with chronic hepatitis C - does the mere presence of the hepatitis C virus have any significant influence on neurocognitive or attentional performance?
• Does the study data support an additional indication for antiviral therapy in chronic hepatitis C? In the case of successful virus eradication, emotional state and - above all - is neurocognitive performance significantly improved even in the absence of severe liver damage?

Conditions

Hepatitis C, Chronic

Keywords

C06.552.380.705.440

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HCV outpatients (University Hospital)

You may qualify if:

• Patients with chronic hepatitis C and indication for interferon-based antiviral therapy.
• Written informed consent to study participation, especially to long-term follow-up monitoring of psychiatric and neurocognitive side effects of combination therapy with (peg)interferon alfa-2b and ribavirin.
• Age of study participants: between 18 and 65 years.
• All patients need to have documented antibodies to hepatitis C virus (HCV) and circulating HCV-RNA as measured by reverse-transcription polymerase chain reaction (Cobas Amplicor HCV Monitor™ test, Roche Diagnostics)

You may not qualify if:

• 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
• Severe internal diseases (e.g., cancer, ischemic heart disease, autoimmune disease)
• Major depressive disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM-IV\] criteria), psychosis, active intravenous drug use or alcohol abuse.

Sponsors & Collaborators

• University of Wuerzburg: lead
• Schering-Plough: collaborator

Study Sites (1)

Med. Klinik und Poliklinik II, University of Wuerzburg

Würzburg, 97070, Germany

Location

Related Publications (4)

• 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.

  PMID: 15637534 BACKGROUND

• 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.

  PMID: 12823087 BACKGROUND

• Kraus MR, Schafer A, Faller H, Csef H, Scheurlen M. Paroxetine for the treatment of interferon-alpha-induced depression in chronic hepatitis C. Aliment Pharmacol Ther. 2002 Jun;16(6):1091-9. doi: 10.1046/j.1365-2036.2002.01265.x.

  PMID: 12030950 BACKGROUND

• Kraus MR, Schafer A, Scheurlen M. Paroxetine for the prevention of depression induced by interferon alfa. N Engl J Med. 2001 Aug 2;345(5):375-6. No abstract available.

  PMID: 11484704 BACKGROUND

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael R. Kraus, MD, PhD

  Med. Klinik und Poliklinik II, University of Wuerzburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Study Start: July 1, 2005
• Study Completion: August 1, 2008
• Last Updated: February 4, 2009

Record last verified: 2009-02

Locations

DE (1)