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Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

This study has been completed.
Sponsor:
Collaborators:
GlaxoSmithKline
Schering-Plough
Information provided by:
Portland VA Medical Center
ClinicalTrials.gov Identifier:
NCT00357045
First received: July 25, 2006
Last updated: NA
Last verified: December 2003
History: No changes posted
  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-Blind
Official Title: Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine; THE HEPDEP II STUDY

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Portland VA Medical Center:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00357045     History of Changes
Other Study ID Numbers: 05-1002
Study First Received: July 25, 2006
Last Updated: July 25, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Paroxetine
Interferons
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
 Pharmacologic Actions
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on June 17, 2013