NCT05457140 · Rady Pediatric Genomics & Systems Medicine Institute
Multiomic Diagnostics in Youth With Psychosis
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Diagnostic rate of brain reactive autoantibodies
Time frame: 2 years
Diagnostic rate of brain reactive autoantibodies via genomic and whole human proteome programmable phage display immunoprecipitation sequencing (PhIP-Seq)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 OR
- 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.
Exclusion criteria
- 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
Where
- San Diego, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 14, 2024 · Source of record for eligibility and locations