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Treatment of Hepatitis C in Psychiatric Patients

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ClinicalTrials.gov Identifier: NCT00751426
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : September 12, 2008
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
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 or disease Phase
Mental Disorders Drug Addiction Phase 4

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.

Study Type : Observational
Actual Enrollment : 81 participants
Official Title: Treatment of Chronic Hepatitis c With Interferon-Alpha 2a and Ribavirin: a Comparison of Patients With Psychiatric Disorders and Controls
Study Start Date : August 1999
Primary Completion Date : February 2002
Study Completion Date : May 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Response
  2. Sustained Virological Response
  3. Adherence
  4. Occurrence of depression
  5. Occurrence of other psychiatric side effects
  6. Long term outcome

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


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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00751426


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

Publications:
Responsible Party: Martin Schaefer, MD
ClinicalTrials.gov Identifier: NCT00751426     History of Changes
Other Study ID Numbers: Psy 225/98
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: September 12, 2008
Last Verified: August 2008

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

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