Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment

Hepatitis C Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133276
• Other study ID #: HCV05-01
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 22, 2005
• Last updated: February 18, 2010
• Start date: August 2005
• Est. completion date: December 2009

Study information

• Verified date: February 2010
• Source: Foundation for Liver Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2009
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis C

Intervention

Drug:
• Escitalopram
OD 5mg for 2 weeks; OD 10mg for 24 weeks; OD 5mg for 2 weeks

Other:
• Placebo

Locations

Country	Name	City	State
Netherlands	AMC	Amsterdam
Netherlands	Radboud University Hospital	Nijmegen
Netherlands	Erasmus MC University Hospital	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Liver Research

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of peginterferon-induced psychiatric disturbance
Secondary	Occurrence of major depression