Hepatitis CNCT00209118
Paroxetine for the Treatment of Interferon Related Side Effects for Hepatitis C
A study testing paroxetine in people with Hepatitis C and Depression, run by Emory University.
Trial 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 IFN(interferon-alpha-2b) 3 times/week (plus ribavirin, 1000-1200 mg/d)) or PEG (polyethylene glycol) interferon-alpha-2b… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Depression, Interferon-alpha Associated Side Effects
- What is being tested?
- paroxetine
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jul 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
About this study
Official title: Paroxetine for the Prevention of IFN-Alpha Associated Depression in Patients With Chronic Hepatitis C
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 IFN(interferon-alpha-2b) 3 times/week (plus ribavirin, 1000-1200 mg/d)) or PEG (polyethylene glycol) interferon-alpha-2b (1.5 micrograms/kg one time a week) and ribavirin (800 to 1,400 mg a day) for chronic hepatitis C (CHC). The IFN plasma half life (t1/2 of 24 to 34 hours) of PEG, a CHC treatment recently approved by the FDA, is significantly prolonged allowing for once a week dosing. Studies indicate that the side effect profile of the two forms of IFN-alpha treatment are very similar. CHC patients will be screened for study eligibility, and a total of 100 CHC patients between the ages of 18 and 65 years old will be enrolled across three sites (30 at Emory site and a combination of 30 from the University of Pennsylvania, Rush-Presbyterian-Saint Lukes Medical Center in Chicago and Montefiore Medical Center in New York.) Two weeks prior to treatment with subcutaneous IFN-alpha-2b, patients who meet inclusion and exclusion criteria will be stratified on the basis of a history of major depression and then randomly assigned to paroxetine or placebo in double blind fashion.
- Being tested
- paroxetine
- Keywords
- Hepatitis C, Interferon-alpha associated side effects, Antidepressants, Prevention
- Medical subject headings
- Hepatitis C, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paroxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptom Scores
Development of Major Depression
Secondary outcomes (3)
neurotoxicity
dosage reduction
discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew H Miller, Emory University
- Investigators
- Andrew H. Miller, MD, Principal investigator, Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209118
- Sponsor's protocol ID
- 0112-1998
- Status last verified
- Apr 2016
- First submitted
- 14 Sep 2005
- Last updated
- 11 Apr 2016
- Results posted
- No
Publications
Raison CL, Woolwine BJ, Demetrashvili MF, Borisov AS, Weinreib R, Staab JP, Zajecka JM, Bruno CJ, Henderson MA, Reinus JF, Evans DL, Asnis GM, Miller AH. Paroxetine for prevention of depressive symptoms induced by interferon-alpha and ribavirin for hepatitis C. Aliment Pharmacol Ther. 2007 May 15;25(10):1163-74. doi: 10.1111/j.1365-2036.2007.03316.x.
PubMed 17451562
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paroxetine for the Prevention of IFN-Alpha Associated Depression in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00209118
- Acronym / sponsor ID
- 0112-1998
- Keywords
- Hepatitis C, Interferon-alpha associated side effects, Antidepressants, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study completion
- Jul 2005
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 IFN(interferon-alpha-2b) 3 times/week (plus ribavirin, 1000-1200 mg/d)) or PEG (polyethylene glycol) interferon-alpha-2b (1.5 micrograms/kg one time a week) and ribavirin (800 to 1,400 mg a day) for chronic hepatitis C (CHC). The IFN plasma half life (t1/2 of 24 to 34 hours) of PEG, a CHC treatment recently approved by the FDA, is significantly prolonged allowing for once a week dosing. Studies indicate that the side effect profile of the two forms of IFN-alpha treatment are very similar. CHC patients will be screened for study eligibility, and a total of 100 CHC patients between the ages of 18 and 65 years old will be enrolled across three sites (30 at Emory site and a combination of 30 from the University of Pennsylvania, Rush-Presbyterian-Saint Lukes Medical Center in Chicago and Montefiore Medical Center in New York.) Two weeks prior to treatment with subcutaneous IFN-alpha-2b, patients who meet inclusion and exclusion criteria will be stratified on the basis of a history of major depression and then randomly assigned to paroxetine or placebo in double blind fashion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paroxetine | Drug | – |
Primary outcome
Depressive Symptom Scores
Development of Major Depression
3 secondary outcomes
neurotoxicity
dosage reduction
discontinuation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Derived from this study: PubMed 17451562Raison CL, Woolwine BJ, Demetrashvili MF, Borisov AS, Weinreib R, Staab JP, Zajecka JM, Bruno CJ, Henderson MA, Reinus JF, Evans DL, Asnis GM, Miller AH. Paroxetine for prevention of depressive symptoms induced by interferon-alpha and ribavirin for hepatitis C. Aliment Pharmacol Ther. 2007 May 15;25(10):1163-74. doi: 10.1111/j.1365-2036.2007.03316.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew H. Miller, MD principal investigator
Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences
Questions about this trial
What is this clinical trial studying?
A study testing paroxetine in people with Hepatitis C and Depression, run by Emory University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptom Scores. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00209118, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2016.