NCT05457140

Multiomic Diagnostics in Youth With Psychosis

Multiomic Diagnostics in Child and Adolescent Psychosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Rady Pediatric Genomics & Systems Medicine Institute · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Psychosis

Interventions

Type	Name	Description
GENETIC	Genetic: Genomic sequencing and molecular diagnostic results, if any.	Genomic sequencing results may be used for diagnosis and treatment of participants.
DIAGNOSTIC_TEST	Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)	Whole Proteome programmable phage display immunoprecipitation sequencing will be used to diagnose known and novel autoantibodies.

Timeline

• Start date: 2022-10-10
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2022-07-13
• Last updated: 2024-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study