Status:
COMPLETED
Paroxetine for the Treatment of Interferon Related Side Effects for Hepatitis C
Lead Sponsor:
Emory University
Conditions:
Hepatitis C
Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A.OVERVIEW This is a 26 week study examining the ability of paroxetine (Paxil) to prevent the development of depression and neurotoxicity in patients receiving either 3 million units of subcutaneous ...
Eligibility Criteria
Inclusion
- age 18-65 years including males, females and minorities
- serum positive for either anti-HCV antibodies or HCV-RNA positive by PCR
- compensated liver disease with the following minimum hematologic and biochemical criteria: hemoglobin 3 g/dl for males; 12 g/dl for females, white blood cell count \> 3,000/mm3, neutrophil count \>1,5000/mm3, platelets \> 100,000/mm3, prothrombin time 2 seconds prolonged compared to control, or equivalent INR ratio, albumin stable and within normal limits, serum creatinine within normal limits, thyroid-stimulating hormone (TSH) within normal limits, direct bilirubin 0.3 mg/dl or within 20% of upper limit of normal (ULN) for local laboratory, indirect bilirubin 0.8 mg/dl or within 20% of ULN for local laboratory, fasting blood sugar 115 mg/dl or within 20% of ULN for non-diabetic patients
- serum hepatitis B surface antigen (HbsAg) negative, antinuclear antibodies (ANA) 1:320
- normal pre-therapy ocular examination if a history of diabetes or hypertension
- hemoglobin A1C \<8.5% if a history of diabetes
- negative pregnancy test for women of childbearing potential, and consent to adhere to adequate contraception or monogamous relationship with a male partner who has had a vasectomy during the treatment period and for 6 months after discontinuation of therapy
- not breast feeding
- documentation and confirmation of adequate contraception in sexually active males
- free from all psychotropic medications for a minimum of 14 days prior to baseline visit (8 weeks for fluoxetine)
Exclusion
- actively meet criteria for major depression within the past six months
- active, effective treatment of depression with an antidepressant within the past three months
- meet criteria for schizophrenia or bipolar disorder (mania) past or present
- actively meet DSM IV criteria for substance abuse/dependence within the past six months
- psychotropic medications within 14 days prior to baseline visit (8 weeks for fluoxetine)
- evidence of untreated or poorly controlled endocrine, cardiovascular, hematological, renal, or neurological disease
- evidence of decompensated liver disease (such as a history or presence of ascites, bleeding varices, spontaneous encephalopathy)
- history of CNS trauma or active seizure disorder requiring medication
- any cause for liver disease other than chronic hepatitis C, such as co-infection with hepatitis B virus and/or human immunodeficiency virus, hemochromatosis, or Wilson's disease
- prior treatment with other (other than IFN-alpha or ribavirin) immunomodulatory drugs, including corticosteroids within 6 months of entry into protocol
- clinical gout
- known hypersensitivity to alpha interferon or ribavirin
- hemoglobinopathies (e.g. thalassemia)
- a positive pregnancy test
- clinically significant retinal abnormalities
- organ transplants
- a score of \<24 on the Mini Mental Status Exam (MMSE)
- prior history of severe adverse events associated with paroxetine
- any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00209118
End Date
July 1 2005
Last Update
April 11 2016
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