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Treatment of Hepatitis C in Psychiatric Patients

This study has been completed.
Sponsor:
Collaborator:
Ludwig-Maximilians - University of Munich
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00751426
First received: September 11, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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 [ Designated as safety issue: Yes ]
  • Sustained Virological Response [ Designated as safety issue: Yes ]
  • Adherence [ Designated as safety issue: Yes ]
  • Occurrence of depression [ Designated as safety issue: Yes ]
  • Occurrence of other psychiatric side effects [ Designated as safety issue: Yes ]
  • Long term outcome [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Psychiatric side effects (group comparison) [ Designated as safety issue: Yes ]
  • Long term outcome after treatment [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Martin Schaefer, MD
ClinicalTrials.gov Identifier: NCT00751426     History of Changes
Other Study ID Numbers: Psy 225/98
Study First Received: September 11, 2008
Last Updated: September 11, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Disease
Hepatitis
Hepatitis C
Mental Disorders
Psychotic Disorders
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Pathologic Processes
RNA Virus Infections
Schizophrenia and Disorders with Psychotic Features
Virus Diseases
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014