Multiomic Diagnostics in Youth With Psychosis

NCT ID: NCT05457140

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-10
• Study Completion Date: 2026-08-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Enrollees - WGS

These participants will be subject to whole genome sequencing and Phage ImmunoPrecipiation sequencing (PhIP-Seq) to identify genetic changes and novel antibodies associated with psychosis.

Group Type: EXPERIMENTAL

Genetic: Genomic sequencing and molecular diagnostic results, if any.

Intervention Type: GENETIC

Genomic sequencing results may be used for diagnosis and treatment of participants.

Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)

Intervention Type: DIAGNOSTIC_TEST

Whole Proteome programmable phage display immunoprecipitation sequencing will be used to diagnose known and novel autoantibodies.

Interventions

Genetic: Genomic sequencing and molecular diagnostic results, if any.

Genomic sequencing results may be used for diagnosis and treatment of participants.

Intervention Type: GENETIC

Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)

Whole Proteome programmable phage display immunoprecipitation sequencing will be used to diagnose known and novel autoantibodies.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Individual in whom one of the following criteria is met:

1. Child/adolescent admitted to the Rady Children's CAPS with symptoms of first break psychosis

OR

2. 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.

1. Already received any prior whole genome sequencing or exome sequencing.

2. Unable to approach the family or patient for enrollment.

3. Unable to obtain informed consent.

4. Family members are ineligible for participation in this study if:

1. They are known to not be genetically related to the child/adolescent patient participant

2. They are a member of a protected research population

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rady Pediatric Genomics & Systems Medicine Institute

OTHER

Sponsor Role: lead

Responsible Party

Aaron Besterman

Psychiatrist, Clinical Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aaron Besterman, MD

Role: PRINCIPAL_INVESTIGATOR

Rady Pediatric Genomics & Systems Medicine Institute

Locations

Rady Children's Hospital San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Aaron Besterman, MD

Role: CONTACT

abesterman@health.ucsd.edu

858-576-1700 ext. 221633

Corrine Blucher, BS

Role: CONTACT

cblucher@rchsd.org

858-576-1700 ext. 221632

Facility Contacts

Aaron Besterman, MD, MD

Role: primary

abesterman@health.ucsd.edu

858-576-1700 ext. 221633

Corrine Blucher, BS

Role: backup

cblucher@rchsd.org

8585761700 ext. 221632

Other Identifiers

801937

Identifier Type: -

Identifier Source: org_study_id