Status:
WITHDRAWN
Chronic Fatigue Syndrome: A Presumptive Mitochondrial Disorder
Lead Sponsor:
Columbia University
Conditions:
Chronic Fatigue Syndrome
Eligibility:
All Genders
25-55 years
Phase:
PHASE2
Brief Summary
The pathogenesis of chronic fatigue syndrome (CFS) is poorly understood and no effective therapy has been developed. Recent studies suggest that a preceding viral infection causes mitochondrial dysfun...
Detailed Description
Chronic fatigue syndrome (CFS), also known as myalgic encephalitis (ME), is clinically characterized as a multisystem illness exhibiting debilitating fatigue, musculoskeletal pain, disturbed sleep, an...
Eligibility Criteria
Inclusion
- Subjects must meet the criteria for CFS of the US Centers for Disease Control and Prevention (CDC), which requires persistent, unexplained fatigue for at least 6 months, concurrent with four of the following:
- impaired memory/concentration
- sore throat, new headaches
- unrefreshing sleep, muscle pain
- multi-joint pain
- tender lymph nodes
- post-exertional malaise
- As well, due to the frequency of visits subjects must currently reside in the greater New York area.
Exclusion
- shortness of breath
- heart disease
- high blood pressure
- other severe chronic illnesses
- clinical depression
- generalized anxiety disorder
- insomnia
- inflammatory arthritis
- anemia
- hypothyroidism
- other conditions associated with significant fatigue
- history of alcohol, tobacco, or drug abuse
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01471652
Start Date
March 1 2012
End Date
February 1 2013
Last Update
April 13 2015
Active Locations (1)
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1
Columbia University Department of Clinical Genetics
New York, New York, United States, 10032