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

This study has been completed.
Information provided by:
VA Office of Research and Development Identifier:
First received: April 15, 2005
Last updated: January 20, 2009
Last verified: May 2007

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
Drug: Citalopram or Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: VISN 20 Prophylactic Treatment of IFN-Induced Depression in Hepatitis C

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

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

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

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
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Please refer to this study by its identifier: NCT00108563

United States, Oregon
VA Medical Center
Portland, Oregon, United States, 97239
Sponsors and Collaborators
VA Office of Research and Development
  More Information Identifier: NCT00108563     History of Changes
Other Study ID Numbers: CLIN-012-02S 
Study First Received: April 15, 2005
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
Hepatitis C
antidepressive agents

Additional relevant MeSH terms:
Depressive Disorder
Hepatitis A
Hepatitis C
Behavioral Symptoms
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Mental Disorders
Mood Disorders
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Antidepressive Agents
Antidepressive Agents, Second-Generation
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors processed this record on May 26, 2016