Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine
Information source: Portland VA Medical Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression
Intervention: Paroxetine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Portland VA Medical Center Official(s) and/or principal investigator(s):
J. K. Moles, M.D., Principal Investigator, Affiliation: Salem VA Medical Center
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 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.
Clinical Details
Official title: Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine; THE HEPDEP II STUDY
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Last updated: July 25, 2006
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