跳至主要内容
临床试验/NCT05457140
NCT05457140招募中不适用

Multiomic Diagnostics in Child and Adolescent Psychosis

Rady Pediatric Genomics & Systems Medicine Institute2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年10月10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
15
试验地点
2
主要终点
Diagnostic rate of brain reactive autoantibodies

研究概览

简要总结

Rady Children's Institute for Genomic Medicine seeks to understand the genomes and immune systems in 15 children and adolescents who are admitted to Rady Children's Hospital Child and Adolescent Psychiatry Service with psychotic symptoms or schizophrenia. Cutting-edge genome and protein sequencing technology will be used to better understand how immunological and genetic assessments may improve our ability to identify the cause of psychosis and impact care. The investigator also hopes to identify new genetic and/or autoimmune causes of psychosis that may inform new treatment for future patients.

详细描述

Schizophrenia is a severe mental illness that often starts in late adolescence or early adulthood where individuals experience changes in how they perceive and interact with the world around them (psychosis). These extreme changes in how one perceives and interacts with the world can cause great distress and have a very negative impact on one's life. In most cases, the cause of schizophrenia or psychosis is unknown. However, in a small subset of people who develop schizophrenia or psychosis, their own immune system creates antibodies that attack the brain, which leads to psychosis (autoimmune psychosis). In another subset of patients, there are specific genetic changes that serve as major risk factors for developing psychosis. Identifying autoimmune and genetic factors associated with psychosis with psychosis can inform diagnosis, treatment and prognosis. However, it is still currently unknown how frequently these autoimmune and genetic factors are present in adolescents presenting to the hospital with their first psychotic episode and whether testing for them impacts care.

The investigator proposes a deep analysis of both genomes and immune systems of 15 children and adolescents who are admitted to Rady Children's Hospital Child and Adolescent Psychiatry Service with new psychotic symptoms or schizophrenia. The investigator plans to use cutting-edge genome and protein sequencing technology to better understand how immunological and genetic assessments may improve our ability to identify the cause of psychosis and impact care. The investigator also hopes to identify new genetic and/or autoimmune causes of psychosis that may inform new treatments for future patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Individual in whom one of the following criteria is met:
  • Child/adolescent admitted to the Rady Children's CAPS with symptoms of first break psychosis
  • Biological parents of child/adolescent enrolled in this study for the purposes of reflex testing. Family members are eligible for participation in this study if they are presumed genetically related to a patient participant.

排除标准

  • Child/Adolescent patients who do not meet any of the inclusion criteria, or those who:
  • Already received any prior whole genome sequencing or exome sequencing.
  • Unable to approach the family or patient for enrollment.
  • Unable to obtain informed consent.
  • Family members are ineligible for participation in this study if:
  • They are known to not be genetically related to the child/adolescent patient participant
  • They are a member of a protected research population

结局指标

主要结局

Diagnostic rate of brain reactive autoantibodies

时间窗: 2 years

Diagnostic rate of brain reactive autoantibodies via genomic and whole human proteome programmable phage display immunoprecipitation sequencing (PhIP-Seq)

次要结局

未报告次要终点

研究者

发起方
Rady Pediatric Genomics & Systems Medicine Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aaron Besterman

Psychiatrist, Clinical Investigator

Rady Pediatric Genomics & Systems Medicine Institute

研究点 (2)

Loading locations...

相似试验

Multiomic Diagnostics in Youth With Psychosis | 临床试验