IMAT: Immune Mechanisms of Antipsychotic Treatment Response

Overview

Overview

We are researching if and how the immune system might affect people with psychosis, and whether treatment with antipsychotic drugs helps improve psychotic symptoms by affecting the immune system.
For this study we are inviting participants that have experienced psychosis symptoms and are starting or changing to a new regular antipsychotic treatment. We want to look at the samples from people with psychosis before and after starting antipsychotic treatment. We are also recruiting a group of control participants that have not experienced psychosis symptoms.
Eligible participants will be invited to two main visits and can take part in one of two ways. They may choose to provide both blood and cerebrospinal fluid (CSF) samples at both visits. Or if they prefer, they can provide only blood samples at each visit. We will also collect information about medical history, mental health and complete some questionnaires.
If you are interested in participating, please inform your care team or treating doctor, who will contact our research team on your behalf if you are suitable for the study.
Your time and travel expenses will be reimbursed.
Are you interested in taking part in this study?

Planned end date

07 Jul 2031 11:41

Conditions

Psychosis,Schizophrenia

Inclusion Criteria

Participants with psychosis symptoms:
  • Age 18-65
  • Currently experiencing psychosis symptoms warranting treatment by secondary care mental health services, as confirmed by a psychiatrist involved in their treatment.
  • Psychosis symptoms likely to be attributable to a disorder represented by ICD codes F20-F39, in the opinion of the treating clinical team.
  • Due to start or change to a new regular antipsychotic medication. - Participants who are initiating antipsychotic treatment for the first time, transitioning to a different antipsychotic medication, or resuming a formerly prescribed antipsychotic medication that was discontinued for a minimum of two weeks may be recruited.
Control Participants
  • Age 18-65
  • No active autoimmune disorder.
  • No history of psychosis symptoms.

Exclusion Criteria

Participants with psychosis symptoms:
  • Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.
  • Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies).
  • Inability to have blood tests.
Control participants:
  • Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.
  • Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies).
  • Inability to have blood tests.
Optional lumbar puncture only:
  • Significant lower spinal deformity (such as spina bifida), injury (such as stenosis) or previous lower spinal surgery.
  • Antiplatelet or anticoagulant therapy within the 14 days prior to Lumbar Puncture procedure.
  • Known or suspected clotting disorder.
  • Clinically significant abnormality in full blood count or clotting screen (prothrombin time (PT) or activated partial thromboplastin time (APTT).
  • Known or suspected raised intracranial pressure, assessed by study clinician.
  • Known or suspected allergy to local anaesthetic agent or an ingredient of the anaesthetic solution.
  • History of chronic or recurrent headaches, in the opinion of the investigator.
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