Treatment of Hepatitis C in Psychiatric Patients

Mental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751426
• Other study ID #: Psy 225/98
• Status: Completed
• Phase: Phase 4
• First received: September 11, 2008
• Last updated: September 11, 2008
• Start date: August 1999
• Est. completion date: May 2002

Study information

• Verified date: August 2008
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: May 2002
• Est. primary completion date: February 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

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 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

Study Design

N/A

Related Conditions & MeSH terms

• Drug Addiction
• Hepatitis C
• Mental Disorders
• Psychotic Disorders

Locations

Country	Name	City	State
Germany	Department of Psychiatry	Munich

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Hepat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response			Yes
Primary	Sustained Virological Response			Yes
Primary	Adherence			Yes
Primary	Occurrence of depression			Yes
Primary	Occurrence of other psychiatric side effects			Yes
Primary	Long term outcome			Yes
Secondary	Psychiatric side effects (group comparison)			Yes
Secondary	Long term outcome after treatment			Yes