Reducing Depressive Symptoms During HCV Therapy: A Randomized Study

Status unconfirmed · Not applicable

Conditions studied: Hepatitis C, Depression

In brief

The purpose of this study is to conduct a randomized controlled trial of an 8-visit non-pharmacologic group intervention in reducing the severity of depressive symptoms in veterans who receive IFN and ribavirin for the treatment of Hepatitis C. We hypothesize that over the first 6 months of treatment with IFN and ribavirin for the 45 patients who receive the 8-visit intervention early in the course of treatment in addition to usual care (experimental group) will have lower scores on the CES-D, a standard depression rating scale, than the 45 patients who receive only usual care (control group).

Key facts

Study ID

NCT00495768

Run by

South Texas Veterans Health Care System

People needed

90

Starts

2004-07-01

Expected to finish

2007-12-01

Last updated by the study team

2007-12-14

Who can join

Age: 25 and older, up to 68. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Eligibility and interest in treatment for chronic HCV (Hepatitis C).
• Absence of co-infection of HIV or Hepatitis B.
• Age 25-68 years old.
• No treatment with IFN (interferon-alpha) in the past 6 months.
• Residence within a 3-hour drive of the clinic.

You may not qualify if…

• Patients must be willing to undergo treatment with PEG-interferon and ribavirin. They must be aware of the side effects of treatment and be motivated to self-administer the medications and come to regularly scheduled appointments.
• Patients with diabetes mellitus must have good glycemic control. Their Hgb A1 c must be <8.0%.
• Patients must not have an active malignancy.
• If patients have a history of severe psychiatric illness or are found to have one by screening with the CES-D, a psychiatrist must approve treatment. If the psychiatric problem is minor, it can be managed by the primary care physician or hepatitis C provider.
• Autoimmune disease, such as autoimmune hepatitis, systemic lupus erythematosis, or sarcoidosis, is a contraindication to treatment.
• Active alcohol or intravenous drug use is a contraindication to treatment.
• Patients with a seizure disorder muct be seizure-free for 6 months prior to treatment.
• Patients with a known history of coronary heart disease are excluded.
• Patients with complications of cirrhosis may not be treatment candidates. Those who have a platelet count of <50,000, large esophageal varices (grade 3-4), uncontrolled ascites, or uncontrolled encephalopathy are excluded.
• Patients with severe mental retardation or dementia are excluded because of difficulty in self-administration of medication and in tolerating the side effects.
• The patient and partner much agree to observe strict contraception to avoid pregnancy, since the medication is fetotoxic up to 6 months after treatment completion.

Where it is running

• South Texas Veterans Healthcare System, Audie Murphy Division — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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