Status:
COMPLETED
Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine
Lead Sponsor:
Portland VA Medical Center
Collaborating Sponsors:
GlaxoSmithKline
Schering-Plough
Conditions:
Major Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00357045
Last Update
July 27 2006
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