Major Depression
Conditions
Brief summary
Objectives: 1. To determine whether paroxetine can prevent major depression in patients with hepatitis C (HCV) who are receiving pegylated-interferon (Peg-IFN). 2. To determine whether paroxetine can prevent subsyndromal increases in depression and anxiety in patients with HCV who are receiving Peg-IFN. 3. To determine whether paroxetine can prevent a significant change in the health related quality of life in patients with HCV who are receiving Peg-IFN. 4. To determine whether paroxetine improves compliance with Peg-IFN therapy for HCV. 5. To determine whether paroxetine enables patients to complete Peg-IFN therapy for HCV who might otherwise require a dose reduction or discontinuation because of neuropsychiatric side effects.
Interventions
DRUGParoxetine
Sponsors
GlaxoSmithKline
Schering-Plough
Portland VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 18 or older * diagnosis of hepatitis C * agree to participate in the study with written informed consent * plan to undergo treatment with Peg-IFN + Ribavirin * compensated liver disease (hemoglobin value \> 12 gm/dL for females or \> 13 gm/dL for males, WBC \> 3000/mm3, platelets \> 70,000/mm3, albumin \> 3.0 g/dL or within 20% of LLN, Serum creatinine \< 1.4 mg/dL, thyroid stimulating hormone within normal limits * confirmation from female patients that adequate contraception is being practiced during treatment period and for 6 months after discontinuation of therapy * confirmation from male patients that acceptable contraception is being practiced
Exclusion criteria
* hypersensitivity to IFN, RBV, or paroxetine * chronic liver disease other than chronic HCV * hemolytic anemia from any cause including hemoglobinopathies * evidence of advance liver disease * any preexisting medical condition that could interfere with participation in the protocol * evidence of cardiac ischemia, a significant unstable cardiac arrhythmia, heart failure, recent coronary artery surgery, uncontrolled HTN, unstable angina, or MI within past 12 months * clinically significant retinal abnormalities * substance abuse (must have abstained from abusing substance for at least 6 months) * diagnosis of major depression in the past 6 weeks * currently receiving full therapeutic dose of antidepressant medications * diagnosis of bipolar disorder * active psychotic condition * active delirium * pregnant female patients, men whose sexual partner is currently pregnant, and men and women who are not practicing adequate contraception * female patients who are actively breast feeding * patients with a known history of non-compliance with medical treatment
Outcome results
None listed