Clinical trial NCT00751426: 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
Overall status: COMPLETED
Conditions: 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.
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2008-09-12
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Study population: HCV-infected Controls, Psychiatric patients, Patients with former drug addiction and patients with methadone substitution

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.

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

Primary outcomes:
measure: Response
measure: Sustained Virological Response
measure: Adherence
measure: Occurrence of depression
measure: Occurrence of other psychiatric side effects
measure: Long term outcome
Secondary outcomes:
measure: Psychiatric side effects (group comparison)
measure: Long term outcome after treatment
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Psychiatry
Study officials:
affiliation: Kliniken Essen-Mitte
name: Martin Schaefer, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.