Treatment of Hepatitis C in Psychiatric Patients

Completed

• Conditions: Mental Disorders; Drug Addiction

• Registration Number: NCT00751426
• Lead Sponsor: 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).

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 Timeline

• Study Start: 1999-08
• Primary Completion: 2002-02
• Study Completion: 2002-05
• Status Verified: 2008-08
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Last Update Submitted: 2008-09-11
• Study First Posted: 2008-09-12
• Last Update Posted: 2008-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response
Sustained Virological Response
Adherence
Occurrence of depression
Occurrence of other psychiatric side effects
Long term outcome

Secondary Outcome Measures

Name	Time	Method
Psychiatric side effects (group comparison)
Long term outcome after treatment

Trial Locations

Locations (1)

Department of Psychiatry; 🇩🇪 Munich, Germany