Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine
NCT ID: NCT00357045
Last Updated: 2006-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
INTERVENTIONAL
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Interventions
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Paroxetine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Schering-Plough
INDUSTRY
Portland VA Medical Center
FED
Principal Investigators
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J. K. Moles, M.D.
Role: PRINCIPAL_INVESTIGATOR
Salem VA Medical Center
Other Identifiers
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05-1002
Identifier Type: -
Identifier Source: org_study_id