Multiomic Diagnostics in Youth With Psychosis

Part of paid clinical trials in San Diego, California.

Sponsor
Rady Pediatric Genomics & Systems Medicine Institute
Study ID
NCT05457140
Status
Recruiting
Apply to this trial

Conditions

  • Psychosis

Eligibility Criteria

Sex
ALL
Age
7 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 10, 2022
Status verified
Nov 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.

Primary Outcome Measure

Diagnostic rate of brain reactive autoantibodies [ Time Frame: 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rady Children's Hospital San DiegoSan DiegoCalifornia92123
Aaron Besterman, MD, MD
[email protected]
858-576-1700
Corrine Blucher, BS
[email protected]
8585761700

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By research site
Rady Children's Hospital San Diego· San Diego, CA

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