Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Drug: Paroxetine

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Collaborators and Investigators

• Sponsor: Portland VA Medical Center
• Collaborators: GlaxoSmithKline; Schering-Plough
• Investigators: Principal Investigator: J. K. Moles, M.D., Salem VA Medical Center

Study record dates

Study Registration Dates

• First Submitted: July 25, 2006
• First Submitted That Met QC Criteria: July 25, 2006
• First Posted (Estimate): July 27, 2006

Study Record Updates

• Last Update Posted (Estimate): July 27, 2006
• Last Update Submitted That Met QC Criteria: July 25, 2006
• Last Verified: December 1, 2003

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: 05-1002