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Prophylaxis of Psychiatric Symptoms During Anti-HCV Treatment

This study has been completed.
Sponsor:
Information provided by:
Foundation for Liver Research
ClinicalTrials.gov Identifier:
NCT00133276
First received: August 22, 2005
Last updated: February 18, 2010
Last verified: February 2010
  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 2
Phase 3

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:


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:

  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 C
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Citalopram
Dexetimide
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014