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Clinical Trials/NCT06687694
NCT06687694
Not yet recruiting
Not Applicable

Immune Mechanisms of Antipsychotic Treatment Response

King's College London1 site in 1 country500 target enrollmentFebruary 2025
ConditionsPsychosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychosis
Sponsor
King's College London
Enrollment
500
Locations
1
Primary Endpoint
Peripheral Immune Phenotype
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this study is to investigate the role of the immune system in psychotic symptoms and their response to treatment. The investigators will collect blood and cerebrospinal fluid samples from participants with psychosis symptoms who are about to start or change to a new regular antipsychotic treatment as well as a control group for comparison.

Participants will be assessed at two main timepoints, at visit 1 (Week 0) and at visit 2 (4 +/-2 weeks). For participants with psychosis symptoms visit 1 will take place at the start or change of antipsychotic medication. The studies goal is to identify biomarkers that can aid in diagnosis, prognosis, treatment selection, and tracking treatment response.

The investigators aim to recruit participants from the following groups:

  1. Individuals with psychosis symptoms presenting to acute or outpatient services who are due to be started on or change to a new regular antipsychotic medication.
  2. Age- and sex-matched control participants without neuropsychiatric disease.

Findings could potentially impact the treatment of psychotic illnesses by offering mechanistic insights into targeted immune-based interventions for these disorders through high-resolution immunophenotyping techniques alongside targeted immunological assays. Ultimately, the research aims to contribute valuable resources for future studies exploring the connection between immune processes and neuropsychiatric conditions.

Registry
clinicaltrials.gov
Start Date
February 2025
End Date
July 2031
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Peripheral Immune Phenotype

Time Frame: 4 +/-2 weeks

Change in the flow cytometric peripheral immune phenotype following treatment with antipsychotic medication.

Study Sites (1)

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