Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

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.

Completed

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paroxetine

Drug

Sponsors and collaborators

Lead sponsor

Portland VA Medical Center

Fed

Collaborators

GlaxoSmithKline
Schering-Plough

Registry information

Official study title

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

Important dates

First posted: Jul 27, 2006
Registry last updated: Jul 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed