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NCT Number: NCT06236048

Energetics and Glutamate in Schizophrenia

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

South London and the Maudsley NHS Foundation Trust

London, United Kingdom

Location status: Recruiting

Location contact

Alice Egerton, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy volunteer group:

  • No history of psychiatric illness, as assessed on the Mini neuropsychiatric Interview (MINI).

Treatment responsive schizophrenia group:

  • Meeting ICD-11 criteria for schizophrenia (F20)
  • 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.
  • Currently receiving one or more of the following antipsychotic medications: Olanzapine; Risperidone; Quetiapine; Amisulpride; Aripiprazole; Paliperidone.
  • Antipsychotic adherent, defined as having a score of >=moderate adherence on the Kemp scale.

Treatment-resistant schizophrenia group:

  • Meeting ICD-11 criteria for schizophrenia (F20)
  • 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.
  • Total PANSS total score > 70
  • Moderate functional impairment (<60 on the SOFAS)
  • Currently receiving one or more of the following antipsychotic medications: Clozapine; Olanzapine; Risperidone; Quetiapine; Amisulpride; Aripiprazole; Paliperidone.
  • Antipsychotic adherent, defined as having a score of >=moderate adherence on the Kemp scale.

Exclusion criteria

All participants:

  • Pregnancy or breastfeeding
  • Lacking in mental capacity to provide informed consent to study participation.
  • 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.
  • 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.

Treatment and study plan

MRI scan

Procedure

7 Tesla MRI scan

PET-MR Scan

Procedure

18F-fluorodeoxyglucose PET-MR scan

Primary outcomes

  1. Brain glucose utilisation

    Time frame: 1 day

    Measured using fully quantitative 18F-fluorodeoxyglucose PET (CMRglc)

  2. Glutamate - anterior cingulate cortex

    Time frame: 1 day

    Glutamate and glutamine measured using magnetic resonance spectroscopy at 7 Tesla

  3. Lactate - visual cortex

    Time frame: 1 day

    Measured using magnetic resonance spectroscopy at 7 Tesla at rest and during visual stimulation

  4. Cerebral blood flow

    Time frame: 1 day

    Measured using arterial spin labelling, 3 Tesla MRI

  5. Cortical network activity

    Time frame: 1 day

    Network activity / connectivity as measured using fMRI at 3 Tesla

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Egerton, PhD

CONTACT

[email protected]

+442078480721

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Acronym: EAGLES

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 1, 2024
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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