Reduction of Body Weight in Olanzapine Treated Schizophrenia Patients by Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PANSS
研究概览
简要总结
This research study helps to demonstrate that adding vitamins and fats (nutritional supplements) to a diet will help reduce body weight and improve the lipid profile. This will be done by examining the body weight and chemicals in the blood. The chemicals are the result of the brain using the fat that subjects eat in their diet. Some medications may also change the amount of these chemicals in a person's blood.
详细描述
To demonstrate that supplementation of antioxidants and omega-3 fatty acids will improve clinical outcome including cognitive performance in olanzapine treated patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 55
- •VA outpatient
- •Diagnosis of schizophrenia by DSM-IV criteria
- •Active treatment with olanzapine
- •Medically healthy
排除标准
- •Diagnosis of MR
- •MMSE score of < 26
- •Not on a stable dose of olanzapine
研究组 & 干预措施
Olanzapine
干预措施: Olanzapine, Omega 3, Vitamin E+C (Drug)
Omega 3
干预措施: Olanzapine, Omega 3, Vitamin E+C (Drug)
Vitamin E +C
干预措施: Olanzapine, Omega 3, Vitamin E+C (Drug)
结局指标
主要结局
PANSS
时间窗: 2003-2006
Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.
BMI
时间窗: 2003-2006
BMI match height and weight.
Blood samples
时间窗: 2003-2006
Samples analyzed, PI analyzed and published. PI no longer with the institution.
次要结局
- Cognitive assessments(2003-2006)