PsychosisNCT05457140
Multiomic Diagnostics in Youth With Psychosis
A study testing Genetic: Genomic sequencing and molecular diagnostic results, if any. and Phage display ImmunoPrecipiation Sequencing (PhIP-Seq) in people with Psychosis, run by Rady Pediatric Genomics & Systems Medicine Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Genetic: Genomic sequencing and molecular diagnostic results, if any. and Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2022to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rady Children's Hospital San Diego
San Diego, California, 92123
Aaron Besterman, MD, MD, 858-576-1700 ext. 221633, abesterman@health.ucsd.edu
Corrine Blucher, BS, 8585761700 ext. 221632, cblucher@rchsd.org
About this study
Official title: Multiomic Diagnostics in Child and Adolescent Psychosis
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.
Read the 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
- Being tested
- Genetic: Genomic sequencing and molecular diagnostic results, if any., Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)
- Keywords
- Genomic, Pediatric, Rady Children's Hospital
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Enrollees - WGS | Experimental | 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. Receives: Genetic: Genetic: Genomic sequencing and molecular diagnostic results, if any.; Diagnostic Test: Phage display ImmunoPrecipiation Sequencing (PhIP-Seq) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic rate of brain reactive autoantibodies
Diagnostic rate of brain reactive autoantibodies via genomic and whole human proteome programmable phage display immunoprecipitation sequencing (PhIP-Seq)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start10 Oct 2022
- Primary completionAug 2025 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rady Pediatric Genomics & Systems Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Besterman, Rady Pediatric Genomics & Systems Medicine Institute
- Investigators
- Aaron Besterman, MD, Principal investigator, Rady Pediatric Genomics & Systems Medicine Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457140
- Sponsor's protocol ID
- 801937
- Status last verified
- Nov 2024
- First submitted
- 8 Jul 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiomic Diagnostics in Child and Adolescent Psychosis
- ClinicalTrials.gov ID
- NCT05457140
- Acronym / sponsor ID
- 801937
- Conditions
- Psychosis
- Keywords
- Genomic, Pediatric, Rady Children's Hospital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Rady Pediatric Genomics & Systems Medicine InstituteUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enrollees - WGS | Experimental | Genetic: Genetic: Genomic sequencing and molecular diagnostic results, if any., Diagnostic Test: Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)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. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic: Genomic sequencing and molecular diagnostic results, if any.Genomic sequencing results may be used for diagnosis and treatment of participants. | Genetic | Enrollees - WGS |
| Phage display ImmunoPrecipiation Sequencing (PhIP-Seq)Whole Proteome programmable phage display immunoprecipitation sequencing will be used to diagnose known and novel autoantibodies. | Diagnostic test | Enrollees - WGS |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aaron Besterman, MD principal investigator
Rady Pediatric Genomics & Systems Medicine Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic: Genomic sequencing and molecular diagnostic results, if any. and Phage display ImmunoPrecipiation Sequencing (PhIP-Seq) in people with Psychosis, run by Rady Pediatric Genomics & Systems Medicine Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aaron Besterman, MD (858-576-1700 ext. 221633, abesterman@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic rate of brain reactive autoantibodies (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.