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

• Status: Withdrawn
• Trial end date: 2017-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deborah Yurgelun-Todd
• Treatments: Cytidine Diphosphate Choline; Rice bran oil

Criteria

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)