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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01515917
• Other study ID #: IRB_53174
• Status: Withdrawn
• Phase: N/A
• First received: January 18, 2012
• Last updated: January 15, 2015
• Start date: November 2013
• Est. completion date: July 2017

Study information

• Verified date: January 2015
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Substance Abuse
• Substance Dependence
• Substance-Related Disorders
• Traumatic Brain Injury

Intervention

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.
• 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:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Deborah Yurgelun-Todd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Brain changes	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	No