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

Chronic Fatigue Syndrome research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Fatigue Syndrome

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Sildenafil (Viagra)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.

Drug:PlaceboPlacebo pills 3X/day for 6 weeks

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

sidenafilsidenafil

placeboplacebo

Study Status

Completed

Start Date: July 2002

Completed Date: December 2010

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Change in Fatigue Impact Scale at 6 Weeks

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Ted C Friedman, M.D., Ph.D.

Lead Sponsor: Charles Drew University of Medicine and Science

Collaborator: Pfizer

More information:https://clinicaltrials.gov/show/NCT00598585

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