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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2010-12-31

Brief Summary

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

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Detailed Description

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

Conditions

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Chronic Fatigue Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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sidenafil

Group Type EXPERIMENTAL

Sildenafil (Viagra)

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pills 3X/day for 6 weeks

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo pills 3X/day for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes