At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- MRI scan (procedure), PET-MR scan (procedure)
- How long the study runs
- Study runs about 57 months (dates as stated)
- About the drug or intervention
- MRI scan — procedure: 7 Tesla MRI scan · PET-MR scan — procedure: 18F-fluorodeoxyglucose PET-MR scan
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 75
- Started
- 2024-03-04
- Last checked
- 2025-03
Plain English Summary
What is this study?
- • Testing a new treatment for schizophrenia
- • Clinical study - 75 participants
- • The goal of this case-control study is to compare brain glutamate, glucose utilisation, lactate production and brain activity in healthy volunteers and people with a diagnosis of schizophrenia
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with schizophrenia
Where?
- • London - South London and the Maudsley NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of this case-control study is to compare brain glutamate, glucose utilisation, lactate production and brain activity in healthy volunteers and people with a diagnosis of schizophrenia. It investigates the following main questions: Whether, compared to healthy volunteers, participants with schizophrenia show: 1. reduction in brain glucose utilisation 2. increased brain lactate 3. greater variability in brain glutamate Participants will be asked to have a screening visit, a MRI brain scan and a PET-MRI brain scan.
Schizophrenia
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What we know so far
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
What the study is looking for
- ✓Healthy volunteer group:
- ✓1\. No history of psychiatric illness, as assessed on the Mini neuropsychiatric Interview (MINI).
- ✓Treatment responsive schizophrenia group:
- ✓Meeting ICD-11 criteria for schizophrenia (F20)
- ✓Currently receiving one or more of the following antipsychotic medications: Olanzapine; Risperidone; Quetiapine;...
Who cannot take part
- ✗All participants:
- ✗Pregnancy or breastfeeding
- ✗Lacking in mental capacity to provide agreement to take part to study participation.
- ✗2\. Diabetes or history of taking an antidiabetic medication 3. Presence of safety concern to MRI at 7 Tesla,...
See the full criteria
Inclusion Criteria:
Healthy volunteer group:
1\. No history of psychiatric illness, as assessed on the Mini neuropsychiatric Interview (MINI).
Treatment responsive schizophrenia group:
1. Meeting ICD-11 criteria for schizophrenia (F20)
2. Meeting symptomatic consensus criteria for remission, defined as scores of mild or less on items P1, P2, P3, N1, N4, N6, G5 and G9 of the PANSS and no history of symptomatic relapse in the past 6 months.
3. Currently receiving one or more of the following antipsychotic medications: Olanzapine; Risperidone; Quetiapine; Amisulpride; Aripiprazole; Paliperidone.
4. Antipsychotic adherent, defined as having a score of \>=moderate adherence on the Kemp scale.
Treatment-resistant schizophrenia group:
1. Meeting ICD-11 criteria for schizophrenia (F20)
2. Meeting modified consensus criteria for treatment resistance, including history of at least two antipsychotic treatment trials each lasting ≥6 weeks at a dose of ≥400mg chlorpromazine equivalents.
3. Total PANSS total score \> 70
4. Moderate functional impairment (\<60 on the SOFAS)
5. Currently receiving one or more of the following antipsychotic medications: Clozapine; Olanzapine; Risperidone; Quetiapine; Amisulpride; Aripiprazole; Paliperidone.
6. Antipsychotic adherent, defined as having a score of \>=moderate adherence on the Kemp scale.
Exclusion Criteria:
All participants:
1. Pregnancy or breastfeeding
2. Lacking in mental capacity to provide informed consent to study participation.
2\. Diabetes or history of taking an antidiabetic medication 3. Presence of contraindication to MRI at 7 Tesla, including metallic or electronic implants and dental wires.
4\. Severe claustrophobia prohibiting participation on PET or MRI 5. Body size above the comfortable limits for the MRI scanner. 6. Previous participation in research or clinical procedure/s involving ionising radiation, which, including the current study, would result in total radiation exposure \>=10mSv within 12 months 7. History of head injury resulting in loss of consciousness for \> 5 minutes 8. Meeting ICD-11 criteria for organic mental disorder (F00-F09) 9. Meeting ICD-11 criteria for mental and behavioural disorders due to psychoactive substance use (F10-F19) 10. With exclusion of nicotine or cannabis, meeting ICD-11 criteria for psychoactive substance dependence 11. Participation in clinical trial investigating any pharmacological agent other than a licensed antipsychotic compound in the last month.
Where Is This Study? (1 UK site)
South London and the Maudsley NHS Foundation Trust
London, United Kingdom
How to Get in Touch
Alice Egerton, PhD
Sponsor contactCONTACT
+442078480721 EAGLES_study@kcl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-03