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VISN 20: Prophylactic Treatment of Interferon-Induced Depression in Hepatitis C Patients

This study has been completed.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00108563
  Purpose

The purpose of this study is to learn more about the effects of interferon and ribavirin combination therapy in people with Hepatitis C. The specific aims are:

  • To assess how often depressive symptoms occur in patients taking combination alpha interferon plus ribavirin or pegylated interferon plus ribavirin therapy for Hepatitis C, when depressive symptoms occur, and how severe the depressive symptoms are when they do occur;
  • To identify potential predictors for the development of depressive symptoms;
  • To identify if citalopram, an antidepressant medication, can prevent or lessen the severity of depressive symptoms brought about by interferon therapy.

Condition Intervention Phase
Hepatitis C
Depression
Drug: Citalopram or Placebo
Phase IV

MedlinePlus related topics:   Antidepressants    Depression    Hepatitis    Hepatitis C   

ChemIDplus related topics:   Ribavirin    Escitalopram    Benzetimide    Citalopram    Citalopram hydrobromide    Dexetimide    Escitalopram oxalate    Interferon alfa-n1    Interferon alfa-2a    Interferon alfa-2b    Interferons   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:   VISN 20 Prophylactic Treatment of IFN-Induced Depression in Hepatitis C

Further study details as provided by Department of Veterans Affairs:

Study Start Date:   October 2003
Estimated Study Completion Date:   September 2006

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Adult male or female, age 18 or older
  • Planning to receive any brand of pegylated interferon/ribavirin combination therapy for chronic HCV (hepatitis C virus)

Exclusion Criteria:

  • Chronic liver disease other than chronic HCV
  • Evidence of advanced liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy
  • A history of organ transplantation
  • Any known preexisting medical condition that could interfere with the patient's participation in the protocol, including: *active seizure disorders requiring medication; *history of major CNS (central nervous system) trauma (as suggested by accident or other event leading to loss of consciousness, personality changes, etc)
  • Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids (e.g. oral or injection).
  • Inability to read and write at a level sufficient to complete self-report forms
  • History of significant non-compliance with medical treatments and appointments
  • Patients currently, or within the last three months, on a full therapeutic dose of antidepressant medication, or a dose of other medication such that it may significantly affect depressive symptomatology
  • Patients with active depression in the previous 3 months and/or those with BDI (Beck Depression Inventory)-II greater than or equal to 15 at the time of study entry.
  • Patients with bipolar disorder or history of bipolar disorder
  • Patients with active psychotic symptoms or diagnosis of schizophrenia in the previous 3 months
  • Active substance abuse, such as alcohol (greater than 80 gm/day), IV (intravenous) drugs, and inhaled drugs. If the patient has a history of substance abuse, in order to be considered for inclusion into the protocol, the patient must have been in a sustained remission for at least 6 months
  • Patients receiving opiate agonist therapy (e.g., methadone maintenance therapy) within the past year, unless a program of testing for continued substance abuse is initiated (testing at entry and then randomly at least every 2-3 months) and the patient is withdrawn from study for any violation.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00108563

Locations
United States, Oregon
VA Medical Center    
      Portland, Oregon, United States, 97239

Sponsors and Collaborators
  More Information


Study ID Numbers:   CLIN-012-02S
First Received:   April 15, 2005
Last Updated:   March 27, 2008
ClinicalTrials.gov Identifier:   NCT00108563
Health Authority:   United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Hepatitis C  
Depression  
Interferon-alpha  
Citalopram
ribavirin
antidepressive agents

Study placed in the following topic categories:
Interferon-alpha
Liver Diseases
Depression
Interferons
Ribavirin
Hepatitis, Viral, Human
Depressive Disorder
Citalopram
Serotonin
Behavioral Symptoms
Hepatitis
Virus Diseases
Digestive System Diseases
Mental Disorders
Mood Disorders
Hepatitis C
Dexetimide
Interferon Alfa-2a
Interferon Alfa-2b

Additional relevant MeSH terms:
RNA Virus Infections
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on October 07, 2008




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