Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

Study Overview
=================
Brief Summary
-----------------
Objectives: To determine whether paroxetine can prevent major depression in patients with hepatitis C (HCV) who are receiving pegylated-interferon (Peg-IFN). To determine whether paroxetine can prevent subsyndromal increases in depression and anxiety in patients with HCV who are receiving Peg-IFN. 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. To determine whether paroxetine improves compliance with Peg-IFN therapy for HCV. 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.

Official Title
-----------------
Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine; THE HEPDEP II STUDY

Conditions
-----------------
Major Depression

Intervention / Treatment
-----------------
* Drug: Paroxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paroxetine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |