Comparing brain activity and metabolism in schizophrenia and healthy individuals

Energetics and Glutamate in Schizophrenia

This study looks at how brain activity and metabolism differ between people with schizophrenia and healthy individuals to better understand the condition.

Quick facts

• Study type: Observational
• Enrollment: 75 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: King's College London (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (London)
• Trial ID: NCT06236048 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate differences in brain metabolism and activity between individuals diagnosed with schizophrenia and healthy volunteers. It will assess brain glucose utilization, lactate production, and glutamate variability using advanced imaging techniques, including MRI and PET-MRI scans. Participants will undergo a screening visit followed by these imaging procedures to gather data on brain function and chemistry. The study seeks to enhance understanding of the neurobiological underpinnings of schizophrenia.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with schizophrenia who are either treatment-responsive or treatment-resistant, as well as healthy volunteers without psychiatric history.

Not a fit: Patients with acute schizophrenia symptoms or those not currently on antipsychotic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the metabolic and neurochemical alterations in schizophrenia, potentially leading to improved treatment strategies.

How similar studies have performed: Other studies have explored brain metabolism in schizophrenia, indicating potential for significant findings, though this specific approach may offer novel insights.

Eligibility 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 this trial is running

London

• South London and the Maudsley NHS Foundation Trust — London, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Alice Egerton, PhD

Conditions Schizophrenia