Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue
Intervention: Sildenafil (Viagra); Placebo
Intervention description: 25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation.; Placebo pills 3X/day for 6 weeks
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients meeting the CDC definition of CFS.

          -  All races, ethnicities, socio-economic status (SES), and gender

          -  Age greater than 18 (because of concerns about radioactivity, we and the Cedars-Sinai
             and Harbor-UCLA IRBs have decided not to enroll subjects below the age of 18).

          -  Age less than 50. Because of concern of sildenafil exacerbating coronary artery
             disease, we will only enroll patients younger than 50.

          -  Able to provide informed consent.

          -  Willingness to be off all medicines and supplements for 3 weeks prior to the study.

          -  Patients with psychiatric disorders (see below) will be included, if they could be off
             their medications, and if their psychiatric diagnosis clearly occurred after their
             fatigue symptoms began.

          -  Patients with concurrent fibromyalgia will be allowed to participate if the meet
             diagnostic criteria for CFS.

        Exclusion Criteria:

          -  Disabilities that would prevent them from participating in the study.

          -  Current use of prescription medicines (starting at 3 weeks prior to the study) and
             supplements (starting at 1 weeks prior to the study) except acetaminophen or aspirin.
             This includes herbal supplements and vitamins.

          -  Existing medical illnesses, such as heart disease, hypertension, cancer,
             rheumatological diseases, endocrinopathies or hormone replacement therapy, seizure
             disorders, severe obesity (BMI > 32 kg/m2),

          -  Severe psychiatric disorders including bipolar disorder, schizophrenia, dementia and
             previous or current diagnosis of alcohol or substance abuse within the past year.
             Patients with depression of such severity as to warrant treatment with
             anti-depressants will be excluded.

          -  Current abuse of illicit drugs or heavy ethanol use.

          -  Pregnant women will be excluded because of radioactivity exposure from the SPECT
             scans.

          -  Abnormal EKG

          -  Abnormal CBC, blood chemistries, thyroid function tests, and HIV, ANA, RF and ESR
             tests.