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Treatment of Hepatitis C in Psychiatric Patients

Primary Purpose

Mental Disorders, Drug Addiction

Status
Completed
Phase
Locations
Germany
Study Type
Observational
Intervention
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Mental Disorders focused on measuring Interferon-alpha, hepatitis c, Drug addiction, methadone, psychiatric disorder, Safety and efficacy of Interferon-alpha i patients with a psychiatric disorder.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry

Outcomes

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

Full Information

First Posted
September 11, 2008
Last Updated
September 11, 2008
Sponsor
Charite University, Berlin, Germany
Collaborators
Ludwig-Maximilians - University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00751426
Brief Title
Treatment of Hepatitis C in Psychiatric Patients
Official Title
Treatment of Chronic Hepatitis c With Interferon-Alpha 2a and Ribavirin: a Comparison of Patients With Psychiatric Disorders and Controls
Study Type
Observational

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
August 1999 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
May 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Ludwig-Maximilians - University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Drug Addiction
Keywords
Interferon-alpha, hepatitis c, Drug addiction, methadone, psychiatric disorder, Safety and efficacy of Interferon-alpha i patients with a psychiatric disorder.

7. Study Design

Enrollment
81 (Actual)
Primary Outcome Measure Information:
Title
Response
Title
Sustained Virological Response
Title
Adherence
Title
Occurrence of depression
Title
Occurrence of other psychiatric side effects
Title
Long term outcome
Secondary Outcome Measure Information:
Title
Psychiatric side effects (group comparison)
Title
Long term outcome after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
HCV-infected Controls, Psychiatric patients, Patients with former drug addiction and patients with methadone substitution
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Schaefer, MD
Organizational Affiliation
Kliniken Essen-Mitte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry
City
Munich
ZIP/Postal Code
80336
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
12540795
Citation
Schaefer M, Schmidt F, Folwaczny C, Lorenz R, Martin G, Schindlbeck N, Heldwein W, Soyka M, Grunze H, Koenig A, Loeschke K. Adherence and mental side effects during hepatitis C treatment with interferon alfa and ribavirin in psychiatric risk groups. Hepatology. 2003 Feb;37(2):443-51. doi: 10.1053/jhep.2003.50031.
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Treatment of Hepatitis C in Psychiatric Patients

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