Drug Addiction, Mental Disorders
Conditions
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
Eligibility
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
| Measure | Time frame |
|---|---|
| Long term outcome | — |
| Occurrence of depression | — |
| Occurrence of other psychiatric side effects | — |
| Response | — |
| Sustained Virological Response | — |
| Adherence | — |
Secondary
| Measure | Time frame |
|---|---|
| Long term outcome after treatment | — |
| Psychiatric side effects (group comparison) | — |
Countries
Germany