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Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00357045
First Posted: July 27, 2006
Last Update Posted: July 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
GlaxoSmithKline
Schering-Plough
Information provided by:
Portland VA Medical Center
  Purpose

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.

Condition Intervention Phase
Major Depression Drug: Paroxetine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine; THE HEPDEP II STUDY

Resource links provided by NLM:


Further study details as provided by Portland VA Medical Center:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357045


Sponsors and Collaborators
Portland VA Medical Center
GlaxoSmithKline
Schering-Plough
Investigators
Principal Investigator: J. K. Moles, M.D. Salem VA Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00357045     History of Changes
Other Study ID Numbers: 05-1002
First Submitted: July 25, 2006
First Posted: July 27, 2006
Last Update Posted: July 27, 2006
Last Verified: December 2003

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Interferons
Antidepressive Agents
Paroxetine
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors