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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Sildenafil (Viagra)
  • 25 mg tid of either Sildenafil(Viagra) or Placebo for first week. 50 mg tid of either Sildenafil (Viagra)or Placebo for second week. 100 mg tid of either Sildenafil (Viagra)or Placebo for 3rd,4th, 5th and 6th week of study participation.
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Double Blind study- one group will be on Sildenafil (Viagra) and the other group will be on placebo.
• Placebo Comparator: 2

Primary Measures

• The principal aim of this study is to determine whether chronic fatigue syndrome (CFS) is due to inadequate blood flow to the brain and to test a medication, Viagra, which should help increase blood flow to the brain and improve the symptoms of CFS.
  • Time Frame: 6 weeks
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 49 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Charles Drew University of Medicine and Science Other

Overall Clinical Trial Officials and Contacts

Ted C Friedman, M.D., Ph.D. Principal Investigator Charles Drew University of Medicine and Science  

Overall Contact: Erik Zuckerbraun, M.D. 310.668.8754 erikzuckerbraun@cdrewu.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00598585

Study ID Number: 02-04-378-07

ClinicalTrials.gov Identifier: NCT00598585

Health Authority: United States: Institutional Review Board

Clinical Trial Research site