- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01515917
Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)
January 15, 2015 updated by: Deborah Yurgelun-Todd
Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Citicoline and Omega-3
At 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.
|
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.
Other Names:
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.
Other Names:
|
Placebo Comparator: Placebo
At 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurocognitive performance
Time Frame: 28 days
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain changes
Time Frame: 28 days
|
Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at Visit 1 (Day 0) and again at Visit 3 (Day 28) in order to determine whether the combined administration of neutraceuticals citicoline and omega-3 fatty acids result in changes to these brain indices in participants with TBI and substance abuse/dependence.
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (Anticipated)
July 1, 2016
Study Completion (Anticipated)
July 1, 2017
Study Registration Dates
First Submitted
January 18, 2012
First Submitted That Met QC Criteria
January 23, 2012
First Posted (Estimate)
January 24, 2012
Study Record Updates
Last Update Posted (Estimate)
January 19, 2015
Last Update Submitted That Met QC Criteria
January 15, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_53174
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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