Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

NCT00357045 | Completed Phase 4

• 1 other identifier: 05-1002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives:

1. 1.To determine whether paroxetine can prevent major depression in patients with hepatitis C (HCV) who are receiving pegylated-interferon (Peg-IFN).
2. 2.To determine whether paroxetine can prevent subsyndromal increases in depression and anxiety in patients with HCV who are receiving Peg-IFN.
3. 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. 4.To determine whether paroxetine improves compliance with Peg-IFN therapy for HCV.
5. 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.

Conditions

Major Depression

Interventions

Paroxetine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Portland VA Medical Center: lead
• GlaxoSmithKline: collaborator
• Schering-Plough: collaborator

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• J. K. Moles, M.D.

  Salem VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 25, 2006
• First Posted: July 27, 2006
• Last Updated: July 27, 2006

Record last verified: 2003-12