Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 49
Updated:4/2/2016
Start Date:July 2002
End Date:December 2010
Contact:Erik Zuckerbraun, M.D.
Email:erikzuckerbraun@cdrewu.edu
Phone:310.668.8754

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Phase 4 Study of the Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With Chronic Fatigue Syndrome.

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

Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood
Flow in Patients with Chronic Fatigue Syndrome.

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.
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