Treatment of Hepatitis C in Psychiatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-08-31

Study Completion Date

2002-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Disorders Drug Addiction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Martin Schaefer, MD

Role: PRINCIPAL_INVESTIGATOR

Kliniken Essen-Mitte

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychiatry

Munich, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT

PMID: 12540795 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Psy 225/98

Identifier Type: -

Identifier Source: org_study_id