Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)

This study is not yet open for participant recruitment.

Verified January 2012 by University of Utah

Sponsor:

Information provided by (Responsible Party):

Deborah Yurgelun-Todd, University of Utah

ClinicalTrials.gov Identifier:

NCT01515917

First received: January 18, 2012

Last updated: February 5, 2013

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 18, 2012
Last Updated Date	February 5, 2013
Start Date ^ICMJE	November 2013
Estimated Primary Completion Date	July 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 23, 2012)	Neurocognitive performance [ Time Frame: 28 days ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01515917 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 23, 2012)	Brain changes [ Time Frame: 28 days ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)
Official Title ^ICMJE	Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Traumatic Brain Injury Substance Abuse Substance Dependence
Intervention ^ICMJE	Drug: Citicoline 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 Name: Cognizin Citicoline Drug: Omega-3 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 Name: Omegabrite Other: Rice bran oil 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. Other: Microcrystalline Cellulose 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.
Study Arm (s)	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. Interventions: Drug: Citicoline Drug: Omega-3 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. Interventions: Other: Rice bran oil Other: Microcrystalline Cellulose
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	July 2017
Estimated Primary Completion Date	July 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01515917
Other Study ID Numbers ^ICMJE	IRB_53174
Has Data Monitoring Committee	Yes
Responsible Party	Deborah Yurgelun-Todd, University of Utah
Study Sponsor ^ICMJE	Deborah Yurgelun-Todd
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Utah
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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