Status:
WITHDRAWN
Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)
Lead Sponsor:
Deborah Yurgelun-Todd
Conditions:
Traumatic Brain Injury
Substance Abuse
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This is a placebo-controlled study intended to examine the effects of the neutraceutical citicholine, together with omega-3 fatty acids, on a range of measures in individuals with concussive head inju...
Eligibility Criteria
Inclusion
- Veteran status
- Age 18 to 55
- History of TBI
- DSM-IV-TR diagnosis of abuse or dependence disorder for either alcohol or drugs of abuse
- Multiple concussive head injuries that meet the following criteria for TBI: 1) normal structural imaging, 2) loss of consciousness (LOC) between 0-30 minutes, 3) alteration of consciousness or mental status for a moment up to 2 hours or 4) post-traumatic amnesia of 0-1 day
- Stable on current psychotropic medication regimen for ≥ 3 months
Exclusion
- Non Veteran
- Significant medical or neurological illness with the exception of TBI, which might affect cognitive function
- Significant medical illness which has the potential to be exacerbated by ingestion of citicoline/omega-3 fatty acids, including diabetes, congestive heart disorder, hyperlipidemia and severe coronary artery disease
- Age other than 18 to 55 years old
- History of ECT treatment
- Estimated IQ \< 70
- Past or present history of bipolar disorder, schizophrenia, delusional disorder or any other psychotic disorder
- Currently taking a prescribed blood thinner (i.e., Coumadin)
- Claustrophobia
- Metal implanted within the body
- Pregnancy or lactation
- Left-handedness
- Poor vision, as subjects must have normal or corrected-to-normal vision for viewing of cognitive challenge paradigms during fMRI protocols
- Non-native English speakers (for neurocognitive tasks)
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01515917
Start Date
November 1 2013
End Date
July 1 2017
Last Update
January 19 2015
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