Serial Comparisons of Abdominal and Neurological MRI Scans of Patients With Refractory Psychosis Disorders
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Abdominal distribution of visceral fat versus subcutaneous fat
研究概览
简要总结
The purpose of this study is to compare abdominal weight gain and fat distribution to changes in brain morphology in people taking antipsychotic medications.
详细描述
Abdominal weight gain is a significant side effect of antipsychotic medications. It has even been suggested to be part of the pathology of severe mental illnesses. Studies have shown that in persons with bipolar disorder, increased body mass index (BMI) is associated with irregular changes in the brain. This association has not been tested in persons with psychosis. In this study, we will be measuring abdominal fat distribution as measured by MRI to see if this is associated with abnormal brain morphology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be admitted to the BC (British Columbia) Psychosis Program at UBC (University of British Columbia) Hospital
- •Must have clinically diagnosed psychosis (e.g. schizophrenia)
- •Must be fluent in English
- •Must not be contraindicated for MRI (i.e., must not be claustrophobic, have metal in the body, be pregnant, have BMI greater than or equal to 40, etc.)
排除标准
- •None, other than those listed above
结局指标
主要结局
Abdominal distribution of visceral fat versus subcutaneous fat
时间窗: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in amounts of visceral and subcutaneous fat as measured by automated segmentation of a magnetic resonance image (MRI)
Changes in total brain volume
时间窗: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in total brain volume as measured by automated segmentation of a magnetic resonance image (MRI).
Changes in grey matter volume in the brain
时间窗: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in amounts of brain grey matter as measured by automated segmentation of a magnetic resonance image (MRI).
Changes in white matter volume in the brain
时间窗: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in amounts of brain white matter as measured by automated segmentation of a magnetic resonance image (MRI).
Changes in the volume of brain structures
时间窗: Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge
Change over time in the volume of brain structures as measured by automated segmentation of a magnetic resonance image (MRI).
次要结局
- Comparing changes in abdominal fat distribution/accumulation to psychosis symptom severity(Baseline (within 2 weeks of admission), 12 weeks later, and prior to discharge)