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Treatment of Hepatitis C in Psychiatric Patients

Treatment of Chronic Hepatitis c With Interferon-Alpha 2a and Ribavirin: a Comparison of Patients With Psychiatric Disorders and Controls

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00751426
Enrollment
81
Registered
2008-09-12
Start date
1999-08-31
Completion date
2002-05-31
Last updated
2008-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Addiction, Mental Disorders

Keywords

Interferon-alpha, hepatitis c, Drug addiction, methadone, psychiatric disorder, Safety and efficacy of Interferon-alpha i patients with a psychiatric disorder.

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.

Interventions

None listed

Sponsors

Ludwig-Maximilians - University of Munich
CollaboratorOTHER
Charite University, Berlin, Germany
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Long term outcome
Occurrence of depression
Occurrence of other psychiatric side effects
Response
Sustained Virological Response
Adherence

Secondary

MeasureTime frame
Long term outcome after treatment
Psychiatric side effects (group comparison)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026