NCT00133276

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2005

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 19, 2010

Status Verified

February 1, 2010

Enrollment Period

2.8 years

First QC Date

August 22, 2005

Last Update Submit

February 18, 2010

Conditions

Hepatitis C

Keywords

Hepatitis CPeg-interferonPsychiatric side-effects

Outcome Measures

Primary Outcomes (1)

  • Occurrence of peginterferon-induced psychiatric disturbance

Secondary Outcomes (1)

  • Occurrence of major depression

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Escitalopram

2

PLACEBO COMPARATOR
Other: Placebo

Interventions

EscitalopramDRUG

OD 5mg for 2 weeks; OD 10mg for 24 weeks; OD 5mg for 2 weeks

Also known as: Lexapro
1
PlaceboOTHER
2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Erasmus MC University Hospital

Rotterdam, South Holland, 3015GD, Netherlands

Location

AMC

Amsterdam, 1100DD, Netherlands

Location

Radboud University Hospital

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Robert J De Knegt, MD

    Erasmus MC University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 23, 2005

Study Start

August 1, 2005

Primary Completion

June 1, 2008

Study Completion

December 1, 2009

Last Updated

February 19, 2010

Record last verified: 2010-02

Locations

NL(3)