Cognizin Citicoline Dosing in a Healthy Adolescent Male Population
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Neurocognitive performance
研究概览
简要总结
To determine the functional effects of Citicoline, a natural supplement, when administered for a duration of four weeks (28 days) to non-psychiatric adolescent male participants. The investigators hypothesize that citicoline will provide cognitive benefits to this population after 28 days of supplementation.
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
- 13 Years 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 13-18 years old
- •No history of co-morbid psychiatric disorder, current Axis I or II diagnosis or previous pharmacotherapeutic trial
排除标准
- •Head injury with LOC > 5 minutes
- •Use of any psychotropic medication
研究组 & 干预措施
High Dose Citicoline
At visit 1 and again at visit 2, participants assigned to the experimental arm will receive a 14-day supply of 500 mg of citicoline, of which they will be instructed to take 500 mg daily. This will be done in a double-blind, randomized fashion.
干预措施: Citicoline (Drug)
Low Dose Citicoline
At visit 1 and again at visit 2, participants assigned to the experimental arm will receive a 14-day supply of 250 mg of citicoline, of which they will be instructed to take 250 mg daily. This will be done in a double-blind, randomized fashion.
干预措施: Citicoline (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: 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 citicoline will improve neurocognitive performance in male adolescents.
次要结局
未报告次要终点
研究者
Deborah Yurgelun-Todd
Professor of Psychiatry
University of Utah