Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Neurocognitive performance
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Citicoline (Drug)
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.
干预措施: Omega-3 (Drug)
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.
干预措施: Rice bran oil (Other)
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.
干预措施: Microcrystalline Cellulose (Other)
结局指标
主要结局
Neurocognitive performance
时间窗: 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.
次要结局
- Brain changes(28 days)
研究者
Deborah Yurgelun-Todd
Professor of Psychiatry
University of Utah