Status:
NOT_YET_RECRUITING
Early Psychosis: Investigating Cognition
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Wellcome Trust
Conditions:
First Episode Psychosis (FEP)
Psychosis
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The project aims to explore changes in brain chemistry in individuals who have recently experienced psychosis. Recent research suggests that chemicals in the brain, specifically one called glutamate, ...
Detailed Description
TRIAL / STUDY BACKGROUND INFORMATION AND RATIONALE Cognitive impairment in psychosis: Cognitive impairments occur in up to 80% of people living with psychosis. The recent landscape report, commissio...
Eligibility Criteria
Inclusion
- Inclusion Criteria for FEP Group (studies 1a and 1b):
- Eligibility criteria for first episode psychosis group are as follows:
- Aged 18-55 years.
- Ability to understand and willing to give written informed consent.
- Fluent in English to be able to understand all cognitive task instructions and questionnaires.
- Current psychotic disorder of less than 5yrs total duration. Defined as meeting DSM-5 criteria consistent with a diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, or severe depression with psychosis.
- At least 8 weeks of stable treatment.
- Ability to travel to the University of Nottingham for in-person testing.
- Exclusion Criteria for FEP Group (Studies 1a and 1b):
- Clinically significant neurological or comorbid psychiatric disorder in the opinion of the investigator.
- History of clinically significant head injury
- Current harmful use of, or dependence on, psychoactive substances (excluding nicotine) in the opinion of the investigator
- Current use of any medication which may interfere with the study in the opinion of the investigator, i.e. any medication that might affect the neurochemicals of interest
- Contraindications for MR scanning as assessed by SPMIC screening form and trained scanner operator (e.g. claustrophobia, pregnancy, metal implants, etc.)
- Contraindications for transcranial direct current stimulation as assessed by standard screening form (e.g. cardiac pacemaker or other implanted devices, seizures, epilepsy, open head wound, etc.)
- Having taken part within the previous month as a participant in a clinical trial that involved taking a drug or having an invasive procedure.
- Inclusion Criteria for Healthy Matched Controls (Studies 1a and 1b):
- Matched healthy control participants will be recruited from a local database of volunteers, from posters and online advertisements.
- Inclusion criteria (matched controls):
- Aged 18 - 55 years.
- Ability to understand and willing to give written informed consent.
- English as first language or fluent in English.
- Ability to travel to the University of Nottingham for in-person testing.
- Exclusion criteria for Health Matched Controls (Studies 1a and 1b):
- Personal or family history of psychosis.
- Clinically significant neurological or psychiatric disorder.
- History of clinically significant head injury.
- Current harmful use of, or dependence on, psychoactive substances (excluding nicotine and caffeine) in the opinion of the investigator.
- Current use of any medication, which may interfere with the study in the opinion of the investigator i.e. any medication that might affect the neurochemicals of interest.
- Contraindications for MR scanning as assessed by SPMIC screening form and trained scanner operator (e.g. claustrophobia, pregnancy etc).
- Contraindications for transcranial direct current stimulation as assessed by standard screening form (e.g. cardiac pacemaker or other implanted devices, seizures, epilepsy, open head wound, etc.)
- Having taken part within the previous month as a participant in a clinical trial that involved taking a drug, being paid an inconvenience allowance, or having an invasive procedure (e.g. venepuncture \>50ml, endoscopy).
- Inclusion Criteria for participants with lived experiences of psychosis (Study 2):
- Aged 18+ years.
- Ability to understand and willing to give written informed consent.
- Fluent in English to be able to understand and answer all questions.
- History of psychotic disorder defined as DSM-5 criteria for diagnosis of schizophrenia, schizoaffective disorder, bipolar affective disorder, or severe depression with psychosis. No limit of time since first episode.
- At least 8 weeks of stable treatment.
- Ability to travel to the University of Nottingham for in-person testing.
- Exclusion Criteria for participants with lived experiences of psychosis (Study 2):
- Clinically significant neurological or comorbid psychiatric disorder.
- Current harmful use of, or dependence on, psychoactive substances (excluding nicotine) in the opinion of the investigator.
- Having taken part within the previous month as a participant in a clinical trial that involved taking a drug or having an invasive procedure.
- Lived experience where psychosis symptoms have not been directly experienced by the individual (e.g., support or carer role to someone else).
Exclusion
Key Trial Info
Start Date :
November 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT07196423
Start Date
November 25 2025
End Date
August 1 2026
Last Update
November 24 2025
Active Locations (1)
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1
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2RD