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

Sponsor

Deborah Yurgelun-Todd (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01515917

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Substance Abuse Substance Dependence	Drug: Citicoline Drug: Omega-3 Other: Rice bran oil Other: Microcrystalline Cellulose	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Jul 1, 2017

Arms and Interventions

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.	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 Names: 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 Names: Omegabrite
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.	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.

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.

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 Names:

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 Names:

Omegabrite

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.

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.

Outcome Measures

Primary Outcome Measures

Neurocognitive performance [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.

Secondary Outcome Measures

Brain changes [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)