Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357045
• Other study ID #: 05-1002
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2006
• Last updated: July 25, 2006

Study information

• Verified date: December 2003
• Source: Portland VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Paroxetine

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Portland VA Medical Center	GlaxoSmithKline, Schering-Plough