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临床试验/NCT02455193
NCT02455193招募中不适用

Neuronal Effects of Exercise in Schizophrenia

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2014年8月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
2
主要终点
Resting-state neuronal response

研究概览

简要总结

This study plans to learn more about how common drugs prescribed to individuals with schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and the brain's response to food. In this study, the investigators will be evaluating how participants' brains respond to food images as well as asking questions about their food preferences and intake and clinical symptoms. The investigators may also ask participants to complete an exercise or diet intervention to see how this changes brain responses or food preferences.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
21 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of schizophrenia or schizoaffective disorder
  • Between 21 and 70 years of age
  • Currently prescribed either olanzapine, risperidone, clozapine, or haloperidol, OR not currently being treated with any neuroleptic medications
  • Weight stable within 5 percent for the last 6 months

排除标准

  • Pregnancy
  • Substance abuse
  • Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia)
  • MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)

结局指标

主要结局

Resting-state neuronal response

时间窗: 14 weeks

Neuronal response (default mode network) during rest

Neuronal response to visual food cues

时间窗: 14 weeks

Neuronal response (insula) while viewing visual food cues

次要结局

  • Fasting leptin(14 weeks)
  • Appetite Rating on a visual analogue scale (VAS)(14 weeks)
  • Fasting ghrelin(14 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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