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

Original Study ID : CLIN-012-02S

NCT ID : NCT00108563

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

Official Title : VISN 20 Prophylactic Treatment of IFN-Induced Depression in Hepatitis C

Brief Summary :

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.

Source : Department of Veterans Affairs

Overall Status : Completed

Start Date : October 2003

End Date : September 2006

Completion Date : September 2006

Official Title : Phase 4

Phase : Interventional

Study Design : Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study

Verification Date : May 2007

First Received Date : April 15, 2005

Trial Eligibility

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.

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : VA Medical Center

City : Portland

State : Oregon

Zip Code : 97239

Country : United States

Interventions

Type : Drug

Name : Citalopram or Placebo

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