Energetics and Glutamate in Schizophrenia

NCT06236048 | Recruiting

• 1 other identifier: 328488
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.reduction in brain glucose utilisation
2. 2.increased brain lactate
3. 3.greater variability in brain glutamate

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (5)

• Brain glucose utilisation

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

  1 day

• Glutamate - anterior cingulate cortex

  Glutamate and glutamine measured using magnetic resonance spectroscopy at 7 Tesla

  1 day

• Lactate - visual cortex

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

  1 day

• Cerebral blood flow

  Measured using arterial spin labelling, 3 Tesla MRI

  1 day

• Cortical network activity

  Network activity / connectivity as measured using fMRI at 3 Tesla

  1 day

Study Arms (3)

Healthy volunteers

Procedure: MRI scan; Procedure: PET-MR scan

Schizophrenia - remission

Procedure: MRI scan; Procedure: PET-MR scan

Treatment resistant schizophrenia

Procedure: MRI scan; Procedure: PET-MR scan

Interventions

MRI scan PROCEDURE

7 Tesla MRI scan

Healthy volunteers; Schizophrenia - remission; Treatment resistant schizophrenia

PET-MR scan PROCEDURE

18F-fluorodeoxyglucose PET-MR scan

Healthy volunteers; Schizophrenia - remission; Treatment resistant schizophrenia

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers - community sample people with a diagnosis of schizophrenia - clinical mental health teams.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

South London and the Maudsley NHS Foundation Trust

London, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for metabolic, mitochondrial markers, glutamate pathways and to determine antipsychotic plasma levels.

MeSH Terms

Conditions

Schizophrenia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Alice Egerton, PhD

CONTACT

+442078480721; EAGLES_study@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 1, 2024
• Study Start: March 4, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the primary analyses are completed and published.

Locations

GB (1)