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New treatment option for First Episode Psychosis (FEP)
Official title Early Psychosis: Investigating Cognition
ClinicalTrials.gov ID: NCT07196423
What this study is testing
- What it's testing
- 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, may behave differently in people who have experienced psychosis compared to those who have not.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- 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...
- Contraindications for MR scanning as assessed by SPMIC screening form and trained scanner operator (e.g. claustrophobia, pregnancy, metal implants...
See the full eligibility 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...
- At least 8 weeks of stable treatment.
- Ability to travel to the University of Nottingham for in-person testing.
- 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...
- 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)...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, Nottinghamshire, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, Nottinghamshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.