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

Deborah Yurgelun-Todd

Status: Withdrawn

Conditions: Traumatic Brain Injury; Substance Dependence; Substance Abuse

Treatments: Drug: Citicoline; Other: Rice bran oil; Other: Microcrystalline Cellulose; Drug: Omega-3

Study type: Interventional

Funder types: Other

Identifiers

NCT01515917

IRB_53174

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Citicoline and Omega-3

Experimental group

Description:

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.

Treatment:

Drug: Omega-3

Drug: Citicoline

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Microcrystalline Cellulose

Other: Rice bran oil