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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

Page last updated: June 20, 2008

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