Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)
1 other identifier
interventional
N/A
0 countries
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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 injury, often referred to as traumatic brain injury, or TBI. The study will consist of three visits, during which participants will complete brain scans, a thorough testing battery and a clinical interview to assess mood and other diagnostic information relevant to the study.
Trial Health
Trial Health Score
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Started Nov 2013
Longer than P75 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 24, 2012
CompletedStudy Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJanuary 19, 2015
January 1, 2015
2.7 years
January 18, 2012
January 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive performance
Using baseline assessment measures gathered at Visit 1, assessments collected at Visits 2 and 3 will be used to determine whether the combined administration of neutraceuticals citicoline and omega-3 fatty acids will improve neurocognitive performance in individuals with TBI and substance abuse/dependence.
28 days
Secondary Outcomes (1)
Brain changes
28 days
Study Arms (2)
Citicoline and Omega-3
EXPERIMENTALAt visit 1 and again at visit 2, participants assigned to the experimental arm will receive a 14-day supply of citicoline and omega-3 fatty acid, of which they will be instructed to take 1000 mg and 2000 mg daily, respectively. This will be done in a double-blind, randomized fashion.
Placebo
PLACEBO COMPARATORAt visit 1 and again at visit 2, participants assigned to the placebo group will be given 14-day supplies of placebo to be taken daily throughout the study period. This will be done in a double-blind, randomized fashion.
Interventions
Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 1000 mg daily citicoline. These participants will receive a 14-day supply of citicoline at visit 1 and again at visit 2, making for a 28-day administration period.
Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 2000 mg daily omega-3. These participants will receive a 14-day supply of omega-3 at visit 1 and again at visit 2, making for a 28-day administration period.
Rice bran oil will be one of two placebos administered to participants randomly assigned to the placebo arm. Rice bran oil will serve as the placebo for omega-3 fatty acids and will be orally administered daily in 500 mg doses.
Microcrystalline Cellulose will be one of two placebos administered to participants randomly assigned to the placebo arm. Microcrystalline Cellulose will serve as the placebo for Citicoline and will be orally administered daily in 470 mg doses.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Psychiatry
Study Record Dates
First Submitted
January 18, 2012
First Posted
January 24, 2012
Study Start
November 1, 2013
Primary Completion
July 1, 2016
Study Completion
July 1, 2017
Last Updated
January 19, 2015
Record last verified: 2015-01