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Treatment of Hepatitis C in Psychiatric Patients

This study has been completed.
Ludwig-Maximilians - University of Munich
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: September 11, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
Psychiatric disorders or drug addiction are often regarded as contraindications against the use of Interferon-alpha in patients with chronic hepatitis C. The investigators aim is/was to get prospective data about adherence, efficacy and mental side effects of IFN-alpha treatment in different psychiatric risk groups compared to controls. In a prospective trial, 81 patients with chronic hepatitis C (positive HCV-RNA and elevated ALT) and psychiatric disorders (n=16), methadone substitution (n=21), former drug addiction (n=21) or controls without psychiatric history or addiction (n=23) should be/were treated with a combination of IFN-alpha-2a 3 x 3 Mio U/week and ribavirin (1000-1200 mg/day).

Condition Phase
Mental Disorders
Drug Addiction
Phase 4

Study Type: Observational
Official Title: Treatment of Chronic Hepatitis c With Interferon-Alpha 2a and Ribavirin: a Comparison of Patients With Psychiatric Disorders and Controls

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Response
  • Sustained Virological Response
  • Adherence
  • Occurrence of depression
  • Occurrence of other psychiatric side effects
  • Long term outcome

Secondary Outcome Measures:
  • Psychiatric side effects (group comparison)
  • Long term outcome after treatment

Enrollment: 81
Study Start Date: August 1999
Study Completion Date: May 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Detailed Description:
Patients from the Munich University outpatient department of psychiatry or gastroenterology as well as inpatients with elevated transaminases were tested for HCV-infection and considered for our trial to avoid a positive or negative selection. Medical inclusion criteria were a detectable serum HCV-RNA level in a PCR-based assay (AMPLICOR®, Roche Diagnostics, Branchburg, NJ) for more than 6 months and an elevated alanine aminotransferase (ALT > 30 U/L, normal <24 U/L). General exclusion criteria were the presence of other liver disease, Child B or C cirrhosis, severe cardiac or neurological disease, co-infection with hepatitis B or HIV, hepatocellular carcinoma evaluated by ultrasound and alpha-fetoprotein, autoimmune disorders, a neutrophil count below 1500 per cubic millimetre, and a platelet count below 75000 per cubic millimetre.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Study Population
HCV-infected Controls, Psychiatric patients, Patients with former drug addiction and patients with methadone substitution

Inclusion Criteria:

  • Medical inclusion criteria were a detectable serum HCV-RNA level in a PCR-based assay (AMPLICOR®, Roche Diagnostics, Branchburg, NJ) for more than 6 months and an elevated alanine aminotransferase (ALT > 30 U/L, normal <24 U/L).

Exclusion Criteria:

  • General exclusion criteria were the presence of other liver disease
  • Child B or C cirrhosis
  • Severe cardiac or neurological disease
  • Co-infection with hepatitis B or HIV
  • Hepatocellular carcinoma evaluated by ultrasound and alpha-fetoprotein
  • Autoimmune disorders
  • Neutrophil count below 1500 per cubic millimetre
  • Platelet count below 75000 per cubic millimetre
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Please refer to this study by its identifier: NCT00751426

Department of Psychiatry
Munich, Germany, 80336
Sponsors and Collaborators
Charite University, Berlin, Germany
Ludwig-Maximilians - University of Munich
Principal Investigator: Martin Schaefer, MD Kliniken Essen-Mitte
  More Information

Responsible Party: Martin Schaefer, MD Identifier: NCT00751426     History of Changes
Other Study ID Numbers: Psy 225/98
Study First Received: September 11, 2008
Last Updated: September 11, 2008

Keywords provided by Charite University, Berlin, Germany:
hepatitis c
Drug addiction
psychiatric disorder
Safety and efficacy of Interferon-alpha i patients with a psychiatric disorder.

Additional relevant MeSH terms:
Hepatitis C
Behavior, Addictive
Mental Disorders
Problem Behavior
Psychotic Disorders
Substance-Related Disorders
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Compulsive Behavior
Impulsive Behavior
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Chemically-Induced Disorders
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017