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

July 25, 2006
July 25, 2006
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No Changes Posted
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Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine
Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine; THE HEPDEP II STUDY

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.
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Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Major Depression
Drug: Paroxetine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
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NCT00357045
05-1002
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Portland VA Medical Center
  • GlaxoSmithKline
  • Schering-Plough
Principal Investigator: J. K. Moles, M.D. Salem VA Medical Center
Portland VA Medical Center
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP