Treatment of Hepatitis C in Psychiatric Patients - Full Text View

Purpose

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).

Condition	Phase
Mental Disorders Drug Addiction	Phase IV

MedlinePlus related topics:

Hepatitis Hepatitis C Mental Health

ChemIDplus related topics:

Methadone Methadone hydrochloride Ribavirin Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons

U.S. FDA Resources

Study Type:	Observational

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

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Response [ Designated as safety issue: Yes ]
Sustained Virological Response [ Designated as safety issue: Yes ]
Adherence [ Designated as safety issue: Yes ]
Occurrence of depression [ Designated as safety issue: Yes ]
Occurrence of other psychiatric side effects [ Designated as safety issue: Yes ]
Long term outcome [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Psychiatric side effects (group comparison) [ Designated as safety issue: Yes ]
Long term outcome after treatment [ Designated as safety issue: Yes ]

Enrollment:	81
Study Start Date:	August 1999
Study Completion Date:	May 2002
Primary Completion Date:	February 2002 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Study Population

HCV-infected Controls, Psychiatric patients, Patients with former drug addiction and patients with methadone substitution

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751426

Locations


Germany
	Department of Psychiatry
	Munich, Germany, 80336

Sponsors and Collaborators

Charite University, Berlin, Germany

Ludwig-Maximilians - University of Munich

Investigators


Principal Investigator:	Martin Schaefer, MD	Kliniken Essen-Mitte

More Information

Publications of Results:

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.

Responsible Party:	( Martin Schaefer, MD )
Study ID Numbers:	Psy 225/98
First Received:	September 11, 2008
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00751426
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

Interferon-alpha

hepatitis c

Drug addiction

methadone

psychiatric disorder

Safety and efficacy of Interferon-alpha i patients with a psychiatric disorder.

Study placed in the following topic categories:

Interferon-alpha

Behavior, Addictive

Liver Diseases

Hepatitis, Chronic

Interferons

Ribavirin

Hepatitis, Viral, Human

Disorders of Environmental Origin

Hepatitis

Virus Diseases

Methadone

Digestive System Diseases

Mental Disorders

Substance-Related Disorders

Hepatitis C

Interferon Alfa-2a

Interferon Alfa-2b

Hepatitis C, Chronic

Additional relevant MeSH terms:

Anti-Infective Agents

RNA Virus Infections

Disease

Flaviviridae Infections

Immunologic Factors

Antineoplastic Agents

Growth Substances

Physiological Effects of Drugs

Antiviral Agents

Angiogenesis Inhibitors

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Growth Inhibitors

Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsors and Collaborators:	Charite University, Berlin, Germany Ludwig-Maximilians - University of Munich
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00751426