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NCT Number: NCT00751426

Treatment of Hepatitis C in Psychiatric Patients

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).

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Key information

Conditions

Mental Disorders Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Digestive System Diseases Drug Addiction Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Substance-Related Disorders Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Psychiatry

Munich, 80336, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Response

  2. Sustained Virological Response

  3. Adherence

  4. Occurrence of depression

  5. Occurrence of other psychiatric side effects

  6. Long term outcome

Secondary outcomes

  1. Psychiatric side effects (group comparison)

  2. Long term outcome after treatment

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Ludwig-Maximilians - University of Munich

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2002
Study completion
2002
First posted
Sep 12, 2008
Registry last updated
Sep 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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