Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment
Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment
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.
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 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 on peginterferon-associated
 psychopathology in patients treated with peginterferon and ribavirin for chronic hepatitis C.

 Design: double blind, randomized controlled trial with two arms, maximum 40 patients per arm.
 Patients, starting with peginterferon and ribavirin, will be randomized to receive
 escitalopram therapy 10 mg per day (however, 5 mg in the first two weeks) or placebo.

 Study population and selection: eighty patients receiving peginterferon alfa-2a (Pegasys 180
 microgram) and ribavirin (Copegus 400 mg twice daily) will be included in the study.

 Aims of the study:

 1. to asses whether prophylactic treatment with escitalopram avoids significantly the
 occurrence of peginterferon-induced psychiatric disturbance; defined as an increase of
 two points on observer-based rating scales reflecting anxiety (BAS:BriefAnxietyScale),
 loss of concentration, depression and loss of impulse control (Montgomery and Asberg
 Depression Rating Scale: MADRS), and

 2. to assess the frequency of major depression according to DSM IV criteria, in the
 escitalopram and placebo-treated patients.
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.