Clinical trial NCT00133276: Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment
Official title: Prophylactic Treatment of Peginterferon-associated Psychopathology. A Double-blind Placebo-controlled Trial on the Effects of Escitalopram (Lexapro®) in Patients Treated With Peginterferon and Ribavirin (POPS Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatitis C
Keywords: Hepatitis C
Peg-interferon
Psychiatric side-effects
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
First posted: 2005-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: Occurrence of peginterferon-induced psychiatric disturbance
Secondary outcomes:
measure: Occurrence of major depression
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC University Hospital
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: AMC
city: Nijmegen
country: Netherlands
facility: Radboud University Hospital
Study officials:
affiliation: Erasmus MC University Hospital
name: Robert J De Knegt, MD
role: PRINCIPAL_INVESTIGATOR
References: