Metabolic Effects of Olanzapine in Patients With Newly Diagnosed Psychosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fasting Insulin
研究概览
简要总结
The purpose of this study was to describe metabolic changes in the first 16 weeks of anti-psychotic treatment in previously drug-naïve patients with psychosis.
We hypothesize that in drug-naive patients, greater insulin resistance prior to treatment predicts a disproportionately greater increase in insulin resistance with olanzapine treatment.
详细描述
Antipsychotic medications are associated with an increased risk of diabetes. We focused on a description of early metabolic adverse effects and clinical and biochemical features that might predict these adverse effects.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Open Trial Group
The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.
干预措施: Olanzapine (Drug)
结局指标
主要结局
Fasting Insulin
时间窗: Baseline and 4 week intervals
Hemoglobin A1c
时间窗: Baseline and 4 week intervals
HDL
时间窗: Baseline and 4 week intervals
LDL
时间窗: Baseline and 4 week intervals
Cholesterol Total
时间窗: Baseline and 4 week intervals
Fasting Glucose
时间窗: Baseline and 4 week intervals
Triglycerides
时间窗: Baseline and 4 week intervals
Body Mass Index
时间窗: Baseline and 4 week intervals
IL-6
时间窗: Baseline and 4 week intervals
次要结局
未报告次要终点
研究者
Brian Kirkpatrick
Professor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)