Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment - Full Text View

Sponsor:	Foundation for Liver Research
Information provided by:	Foundation for Liver Research
ClinicalTrials.gov Identifier:	NCT00133276

Purpose

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.

Condition	Intervention	Phase
Hepatitis C	Drug: Escitalopram Other: Placebo	Phase II Phase III

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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by Foundation for Liver Research:

Primary Outcome Measures:

Occurrence of peginterferon-induced psychiatric disturbance

Secondary Outcome Measures:

Occurrence of major depression

Estimated Enrollment:	80
Study Start Date:	August 2005
Study Completion Date:	December 2009
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Escitalopram OD 5mg for 2 weeks; OD 10mg for 24 weeks; OD 5mg for 2 weeks Other Name: Lexapro
Placebo Comparator: 2	Other: Placebo

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:

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133276

Locations

Netherlands
Erasmus MC University Hospital
Rotterdam, Zuid-Holland, Netherlands, 3015GD
AMC
Amsterdam, Netherlands, 1100DD
Radboud University Hospital
Nijmegen, Netherlands, 6500 HB

Sponsors and Collaborators

Foundation for Liver Research

Investigators

Principal Investigator:

Robert J De Knegt, MD

Erasmus MC University Hospital

More Information

No publications provided

Responsible Party:	Dr. R.J. de Knegt, Foundation for Liver Research
ClinicalTrials.gov Identifier:	NCT00133276 History of Changes
Other Study ID Numbers:	HCV05-01
Study First Received:	August 22, 2005
Last Updated:	February 18, 2010
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Foundation for Liver Research:

Hepatitis C
Peg-interferon
Psychiatric side-effects

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents

Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012