Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The treatment of chronic hepatitis C with peginterferon and ribavirin is highly effective but is hampered by peginterferon-induced psychopathology.

Prevention of peginterferon-induced psychopathology with selective serotonin reuptake inhibitors (SSRI's) (paroxetine) has been shown to be effective in patients treated with interferon for malignant disease. The aim is to study the effects of prophylactic treatment with escitalopram (another SSRI) on peginterferon-associated psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis C.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Foundation for Liver Research
• Treatments: Citalopram; Dexetimide

Criteria

Inclusion Criteria:

• Male and female patients between 18-70 years of age

• Evidence of chronic hepatitis C by detectable serum HCV-DNA

• Hepatitis C genotype 1,2,3 or 4

• Indication for antiviral therapy of hepatitis C according to current clinical guidelines

• Written informed consent

Exclusion Criteria:

• History or other evidence of severe illness, malignancy or any other condition which would make the patient, in the opinion of the investigator, unsuitable for the study

• Abnormal thyroid stimulating hormone (TSH)

• Presence of contra-indications for antiviral therapy

• Concurrent psychiatric axis I diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria, as the presence of a major depressive episode, bipolar disorder or psychotic disorder.

• Concurrent use of psychotropic drugs such as MAO-inhibitors, St John's wort, Lithium and 5 HT-agonists and antiepileptics.