Brain Correlates of Olanzapine Treatment Response in BPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan
研究概览
简要总结
The overall design of the study is to perform both a PET and MRI scan on objectively identified borderline personality disorder patients, to treat them with olanzapine for 8 weeks, and to then re-scan the patients with PET.
详细描述
The primary objective of this proposed study will be to compare the baseline PET scan to the endpoint scan in 15 BPD patients who have been treated with olanzapine. The comparison of the scans will be done through a statistical image analysis, using a pixel-by-pixel group mean subtraction strategy with appropriate correction for multiple comparisons. In an exploratory fashion we will compare frontal and temporal regions of interest to address hypotheses of which areas of the brain might show changes with olanzapine treatment.
A secondary objective is to use a normal database to compare the baseline PET scan of the 15 patients in a medication free state to normal subjects. The advantage of this strategy is the ability to closely match subjects by gender and age. As noted earlier, Dr. Pardo has data on 35 control subjects studied on the same scanner we plan to use for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-45 years
- •Diagnosis: borderline personality disorder by DSM-IV criteria
- •Gender: Female
- •May have history of substance use and other Axis II disorders
排除标准
- •Axis I diagnosis of schizophrenia, schizoaffective disorder, or bipolar I disorder during the subject's lifetime. No current major depression or PTSD.
- •Treatment with psychotropic medication in the previous month.
- •Medical disorder that would influence outcome of the study - e.g. epilepsy, thyroid disease, HIV, etc.
- •Medical disorder that would not allow use of olanzapine
- •Active substance abuse or dependence
- •Previous adverse reaction to olanzapine
- •Females whom are pregnant or nursing
研究组 & 干预措施
Open-label Olanzapine.
Open-label Olanzapine.
干预措施: olanzapine (Drug)
结局指标
主要结局
Change in Brain Metabolism From Baseline to Eight Weeks as Seen in PET Scan
时间窗: Baseline to 8 weeks
The primary aim of this imaging study was to examine the effect of olanzapine on brain metabolism over the eight weeks of administration. To compare the baseline PET scan to the endpoint scan,
次要结局
未报告次要终点