Chronic Fatigue Syndrome
Conditions
Brief summary
Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)
Detailed description
Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.
Interventions
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.
DRUGPlacebo
Placebo pills 3X/day for 6 weeks
Sponsors
Pfizer
Charles Drew University of Medicine and Science
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fatigue Impact Scale at 6 Weeks | 6 weeks | change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sildenafil Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. | 6 |
| Placebo Placebo: Placebo tid for 6 weeks | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Sildenafil |
|---|---|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 9 | 38 years STANDARD_DEVIATION 5 | 39 years STANDARD_DEVIATION 6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 9 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
Primary
Change in Fatigue Impact Scale at 6 Weeks
change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sildenafil | Change in Fatigue Impact Scale at 6 Weeks | -32.6 units on a scale | Standard Deviation 31.5 |
| Placebo | Change in Fatigue Impact Scale at 6 Weeks | -1.5 units on a scale | Standard Deviation 12.2 |
p-value: <0.05t-test, 2 sided