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:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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 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
Estimated Study Completion Date:	December 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Escitalopram OD 5mg for 2 weeks; OD 10mg for 24 weeks; OD 5mg for 2 weeks
2: Placebo Comparator	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
Radboud University Hospital
Nijmegen, Netherlands, 6500 HB
AMC
Amsterdam, Netherlands, 1100DD
Netherlands, Zuid-Holland
Erasmus MC University Hospital
Rotterdam, Zuid-Holland, Netherlands, 3015GD

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:	Foundation for Liver Research ( Dr. R.J. de Knegt )
Study ID Numbers:	HCV05-01
Study First Received:	August 22, 2005
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00133276 History of Changes
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:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Liver Diseases
Neurotransmitter Agents
Flaviviridae Infections
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Hepatitis, Viral, Human
Cholinergic Agents
Therapeutic Uses
Hepatitis C

Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
RNA Virus Infections
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Virus Diseases
Hepatitis
Muscarinic Antagonists
Serotonin Agents
Digestive System Diseases
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010