跳至主要内容
临床试验/NCT04639388
NCT04639388招募中不适用

Characterize the Behavioral Prodromes of Psychotic Disorders in Children With 22q11.2DS Aged From 4 to 13 Years Old

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
2
主要终点
The Screen for child Anxiety Related Emotional Disorders (SCARED)

研究概览

简要总结

The study PremiCeS22 will investigate the prodromal signals at the onset of psychotic disorders of children with 22q11.2 deletion syndrome

详细描述

22q11.2DS is one of the most common microdeletion syndromes (1 / 2000-1 / 4000 births) and one of the most robust genetic risk factors for schizophrenia (1 to 2% of cases). Reciprocally, approximately 30% of patients with 22q11.2DS will develop psychotic symptoms in adolescence or early adulthood. It is now well established that children and adults with 22q11.2DS have lower social skills than developing youth. These social dysfunctions could be partly underpinned by alterations in social cognitive processes, and could also be linked to the emergence of psychotic signs or even schizophrenia. However, to our knowledge, no study has investigated the existence of behavioral prodromal signs during the onset of psychotic signs in children with 22q11.2DS. In addition, the origin of social cognitive processes remains to this day little explored.

研究设计

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

入排标准

年龄范围
4 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of 22q11.2 deletion syndrome or no developmental disease
  • Aged from 4 to 13 years old
  • French language

排除标准

  • Diagnosis of intellectual deficiency according to DSM 5 criteria
  • Drug prescribed for somatic condition that could influence cerebral functioning

结局指标

主要结局

The Screen for child Anxiety Related Emotional Disorders (SCARED)

时间窗: Day 1

Scale assessing behavioral prodromes or warning signs of hallucinations in psychotic disorders A psychometric study is then carried out on this questionnaire in order to validate it with parents of children carrying 22q11.2DS.

facial expression recognition task

时间窗: Day 1

Proportion of correct responses in experimental tasks evaluating gaze direction and facial expression recognition

次要结局

  • Rey's Tangled Lines Test(Day 1)
  • Sustained hearing attention test (Tea-Ch battery)(Day 1)
  • NEPSY II battery(Day 1)
  • Mean reaction time(Day 1)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

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