Psychosis Immune Mechanism Stratified Medicine Trial: The PIMS Trial

niversity of Bristol0 sites120 target enrollmentJuly 13, 2022

Overview

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36963796/ (added 10/05/2023)

Registry

who.int

Start Date

July 13, 2022

End Date

May 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Bristol

•Inclusion Criteria for All Participants
•1\. Able and willing to give informed consent, including consent to share information with the participant’s General Practitioner (GP) and to access secondary care and GP records.
•2\. Able to understand written and spoken English.
•3\. Willing to consent to blood sampling.
•4\. Willing to abstain from strenuous exercise for 72 hours before the assessment visits.
•5\. Age: 18 \- 40 years (inclusive) at the time of eligibility assessment.
•Additional Inclusion Criteria for Neuroimaging
•6\. Able and willing to consent to MRI scanning.
•Additional Inclusion Criteria for Healthy Controls
•7\. No current or lifetime psychiatric diagnosis.

•Exclusion Criteria for All Participants
•1\. Pregnancy (confirmed by urine pregnancy test) or breast feeding.
•2\. Body mass index (BMI) \>35 kg/m² (i.e., WHO obesity class II or above).
•3\. Current or lifetime diagnosis of antisocial personality disorder, autism or other neurodevelopmental disorder, major traumatic brain injury (determined by Chief Investigator).
•4\. Currently active diagnosed eating disorder likely to compromise ability to take part (determined by Chief Investigator).
•5\. History of alcohol or substance use disorder (abuse/dependence) within six months prior to eligibility assessment (nicotine and caffeine dependence are not exclusionary).
•6\. Current use of medication likely to compromise interpretation of immunological data (including, but not limited to, antibiotics, regular non\-steroidal anti\-inflammatory drugs, oral/injectable corticosteroids – or any other substances to be determined by the Chief Investigator).
•7\. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections.
•8\. Current or past infection including tests for TB, Hepatitis B, Hepatitis C, VZV or HIV confirmed by blood test. Chest X\-ray will be also done to exclude TB.
•9\. Any major episode of infection requiring hospitalisation or treatment with IV antibiotics within 4 weeks of eligibility assessment.