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临床试验/NCT02524301
NCT02524301已完成不适用

Evaluation of Brain Opioid Receptor Activity in Anorexia Nervosa : a PET [11C]Diprenorphine Study

Centre Hospitalier Universitaire de Saint Etienne3 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
3
主要终点
[11C]diprenorphine binding potential

研究概览

简要总结

The place of opioid system in anorexia nervosa (AN) physiopathology is still unclear. Conflicting results were published on cerebral spinal fluid or peripheral levels in anorexia nervosa. However, no data have been reported on opioid cerebral activity. Diprenorphine is a ligand with non-selective binding to opiate receptors µ, κ and δ capable to assess the interaction between endogenous opioids and their receptors.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • AN patients DSM IV criteria including amenorrhea BMI < 17.5 kg/m² and abnormal nutritional markers Group 1 (N=15) : long period of / recurrent weight loss (> 2 yrs) Group 2 (N=15) : recent weight loss (6 to 12 months)
  • Recovered AN patients History of AN Weight recovery and BMI > 18.5 kg/m², stable for at least 12 months Normal nutritional markers Group 1 (N=15) : menses recovery after bodyweight stabilization Group 2 (N=15) : long persistence of amenorrhea (> 12 months) despite weight recovery
  • Healthy volunteers (N=15) BMI between 18.5 and 25 kg/m², normal nutritional markers, absence of psychiatric or organic pathology
  • For all subjects Women 18-35 yrs Written and sign consent Affiliation to health insurance

排除标准

  • History of heart failure
  • Psychotropic treatment , antiepileptics
  • Ongoing or suspected pregnancy, positive beta HCG test before brain imaging
  • Intense physical activity
  • Constrains for MRI (ferromagnetic implants or claustrophobia)
  • Refusal to be informed in case of incidentaloma revealed by brain imaging
  • Refusal for written consent

研究组 & 干预措施

anorexia nervosa patients

Experimental

Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

干预措施: Positron Emission Tomography using [11C]diprenorphine (Drug)

Recovered anorexia nervosa patients

Experimental

Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

干预措施: Positron Emission Tomography using [11C]diprenorphine (Drug)

Healthy Volonteers

Experimental

Cerebral [11C]diprenorphine Binding Potential measured by Positron emission Tomography (PET)

干预措施: Positron Emission Tomography using [11C]diprenorphine (Drug)

结局指标

主要结局

[11C]diprenorphine binding potential

时间窗: week 2

Value of \[11C\]diprenorphine binding potential (BP) in predefined brains regions \[11C\] diprenorphine BP will be evaluated by brain positron emission tomography

次要结局

  • Correlation [11C]diprenorphine binding potential(week 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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