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临床试验/NCT02333500
NCT02333500已完成不适用

Pilot Study: a Comparative Study Between Serum Levels of Oxytocin and Incitement to Use Olfactory Stimuli in Restrictive Anorexia Nervosa in Adolescents

Fondation Lenval1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Score "Wanting" to olfactory stimuli

研究概览

简要总结

This prospective pilot study will compare adolescents with restrictive anorexia nervosa who participated for 3 months at olfactory workshops, patients who did not, and healthy patients.The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

详细描述

The restrictive anorexia nervosa (AN) in adolescents is an eating disorder with decreased desire to eat (wanting) following olfactory stimulation. Oxytocin is an hormone involved in the neuromodulation of eating behavior, but also involved in olfactory perception in schizophrenia patients, and in social cognition in patients with autism. Its plasma level was found low in anorexic patients compared to control subjects.

Because of the similarity in disorders of social cognition between these three diseases, we assume that the desire to eat evoked by olfactory perception varies with the plasma oxytocin levels.

With a prospective pilot study we will compare patients with AN who participated for 3 months at olfactory workshops, AN patients who did not, and healthy patients.

The groups will be evaluated before the workshops and after three months, with the wanting score after olfactory stimuli and with serum oxytocin level.

One application of this study will be the use of ocytocyne nasal spray to increase the eating desire and to allow weight regain

研究设计

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

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Medical-Review
  • •Female or male -Sexe,
  • •11 to 18 years
  • •Anorexia nervosa diagnosed according to the criteria DSM V
  • •Outpatient care or hospitalization
  • •Be able to answer the clinicals evaluations questionnaires
  • •Affiliated to social security
  • •Consentement of the legal representative and the patient

排除标准

  • •Somatic comorbidity associated with diabetes, celiac disease, brain tumor
  • •Intolerance odors, predisposed to develop asthma and / or respiratory allergies Pathologie chronic rhino-sinus
  • •Hyposmiques or anosmic
  • •Patients not of an inclusion criteria

研究组 & 干预措施

olfactory workshop

Experimental

Influence of sensory therapy on the rate of oxytocin

干预措施: olfactory workshop (Other)

other workshop

Active Comparator

Influence of other workshop on the rate of oxytocin

干预措施: other workshop (Other)

control group

Other

Rate of oxytocin of the control group

干预措施: No intervention (Other)

结局指标

主要结局

Score "Wanting" to olfactory stimuli

时间窗: at 3 months

次要结局

  • Body mass index(at 3 months)
  • Oxytocin serum level(at 3 months)
  • Scores to clinical scales(at 3 months)
  • Scores to "liking"-"wanting" tests(at 3 months)
  • Scores to hedonicity scale(at 3 months)

研究者

发起方
Fondation Lenval
申办方类型
Other
责任方
Sponsor

研究点 (1)

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