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Inflammation, Stress and Social Behavior: Using Ecological Assessments and Model Systems to Enhance Relevance to Health Outcomes

21 Years
65 Years
Open (Enrolling)
Hepatitis C

Thank you

Trial Information

Inflammation, Stress and Social Behavior: Using Ecological Assessments and Model Systems to Enhance Relevance to Health Outcomes

Inclusion Criteria:

- Age 21-65 years including males, females and minorities

- Ability to speak and read remedial English

- 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 ≥13 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 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

- Negative pregnancy test for women of childbearing potential, and confirmation and
documentation that 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 breastfeeding

- Documentation and confirmation of adequate contraception in sexually active males

- Free from all psychotropic medications for 14 days prior to baseline visit (8 weeks
for fluoxetine)

Exclusion Criteria:

- 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 narcolepsy, PLMS or sleep apnea (or documented during the adaptation

- 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

- Prior treatment with ribavirin or other antiviral or immunomodulatory drugs,
including corticosteroids within 6 months of entry into protocol

- Chronic use of agents known to affect monoamine metabolism/function (and hence
potentially affect the TSST), including, but not limited to, alpha- and beta-receptor
agonists and antagonists, methylphenidate hydrochloride, dextroamphetamine, midodrine
hydrochloride, theophylline, ephedrine, systemic antifungal azoles, sumatriptan

- Psychotropic medications within 14 days prior to baseline visit (8 weeks for

- Clinical gout

- Hypersensitivity to alpha interferon or ribavirin

- Hemoglobinopathies (e.g. thalassemia)

- A positive pregnancy test

- Organ transplants

- A score of <24 on the Mini Mental Status Exam (MMSE)

- Active, effective treatment of depression with an antidepressant within the past six

- Actively meet criteria for major depression within the past six months

- Meet criteria for schizophrenia or bipolar disorder (mania) past or present

- Active abuse of alcohol or illicit/prescription drugs within the past year 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Outcome Measure:

Percent time laughing

Outcome Time Frame:

7 weeks

Safety Issue:


Principal Investigator

Charles L. Raison, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arizona


United States: Institutional Review Board

Study ID:




Start Date:

June 2012

Completion Date:

June 2016

Related Keywords:

  • Hepatitis C
  • Hepatitis C
  • interferon
  • stress
  • social behavior
  • Hepatitis
  • Hepatitis A
  • Hepatitis C
  • Inflammation



University of ArizonaTucson, Arizona  85724
Emory UniversityAtlanta, Georgia  30322