NCT00196664

Brief Summary

Depression is a common side effect of interferon in the treatment of chronic hepatitis C. The aim of this study is to assess the efficacy and safety of paroxetine, an antidepressant agent, in the prevention of depression induced by PEG-interferon given for the treatment of chronic hepatitis C.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2005

Typical duration for phase_3

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

May 13, 2009

Status Verified

May 1, 2009

First QC Date

September 13, 2005

Last Update Submit

May 12, 2009

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis CParoxetineDepression

Outcome Measures

Primary Outcomes (1)

  • Incidence of depression based on MINI International Neuropsychiatric Interview (MINI, DSM IV)from D0 to W74

Secondary Outcomes (1)

  • Evolution of depression score (MADRS and BDI scales) to W74,Quality of life (HQL questionnaire), Fatigue, Compliance to PEG-interferon and ribavirin, Virological response at W74 ,Safety

Interventions

ParoxetineDRUG

Eligibility Criteria

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

You may qualify if:

  • \- Chronic hepatitis C which should be treated by PEG-interferon alfa and ribavirin with no contra-indication to anti-viral treatment

You may not qualify if:

  • Allergy to paroxetine
  • Current antidepressant treatment
  • Depression diagnosed by the MINI International Neuropsychiatric Interview (MINI, DSM IV)
  • History of bipolar syndrome
  • History of psychotic syndrome
  • Treatment by triptan, carbamazepine, millepertuis, methadone, oral anticoagulation
  • Renal insufficiency
  • HIV infection
  • Breath feeding
  • Contra-indication to PEG-interferon and or ribavirin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Hépato-gastroentérologie CHU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Hepatitis C, ChronicDepression

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jean Pierre Bronowicki, MD, PhD

    Service d'Hépato-gastroenterologie, CHU de Nancy, Vandoeuvre France

    PRINCIPAL INVESTIGATOR

  • Faiez Zannad, MD

    C.I.C Nancy France

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

October 1, 2005

Study Completion

February 1, 2009

Last Updated

May 13, 2009

Record last verified: 2009-05

Locations

FR(1)