How the schizophrenia brain uses ketones and glucose

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a non-interventional PET neuroimaging pilot that measures brain ketone and glucose metabolism in antipsychotic-naïve first-episode schizophrenia patients and matched healthy controls. Patients undergo PET imaging at baseline before starting antipsychotics and again after 4–8 weeks of treatment, with an additional clinical follow-up at six months, while controls have a single baseline visit. The investigators aim to recruit 22 patients to allow for an expected 50% dropout and obtain about 12 full datasets. The study focuses on metabolic substrate use (ketone bodies versus glucose) to characterize early illness changes and short-term effects of antipsychotic exposure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Inclusion criteria for patients with FES

1. Age 18-35 years
2. Diagnosed with FES (ICD-10: F20)
3. Able to give informed oral and written consent.

Inclusion criteria for healthy controls

1. Age 18-35 years
2. No mental disorder (ICD-10: F00-99)
3. Able to give informed oral and written consent.

Exclusion Criteria:

Exclusion criteria for patients with FES

1. Any coercive measure including patients in forensic psychiatry
2. In a clinical condition where the treating clinician evaluates that the patient is not able to attend the research study.
3. Previous use of AP at an antipsychotic dose (except for Risperidone ≤0.5 mg, Abilify ≤2.5 mg, Seroquel ≤50 mg or Zyprexa ≤2.5 mg) for more than 2 continuous weeks in the past year and/or 6 weeks over a lifetime
4. Use of an antipsychotic in the last 3 months before inclusion at a dose greater than:

   4.1 Seroquel/Quetiapine 50 mg 4.2 Risperdal/Risperidone 0.5 mg
5. Comorbidity: Borderline intelligence or intellectual disability, autism spectrum disorder, decompensated substance use disorder, psychosis induced by a medical condition or psychosis induced by medication or drug use.
6. Pregnancy, childbirth within the past 6 months, or breastfeeding. Female participants should use an effective contraception.
7. Contraindications to MRI (metal, severe claustrophobia).
8. Acute suicidal thoughts (e.g., resulting in hospitalization)
9. Diabetes mellitus type 1. History of severe head trauma, stroke, chemotherapy or brain surgery. Hypo- or hyperthyroidism. Epilepsy. Systemic glucocorticoid hormone treatment.
10. Other conditions interfering with participation according to the qualified physician's judgment.

Exclusion criteria for healthy controls

1. Previous use of an antipsychotic dose (except for Risperidone ≤0.5 mg, Abilify ≤2.5 mg, Seroquel ≤50 mg or Zyprexa ≤2.5 mg) for more than 2 continuous weeks in the past year and/or 6 weeks over a lifetime
2. Use of AP in the last 3 months before inclusion at a dose greater than:

   1. Seroquel/Quetiapine 50 mg
   2. Risperdal/Risperidone 0.5 mg
3. Pregnancy, childbirth within the past 6 months, or breastfeeding. Female participants should use an effective contraception.
4. Contraindications to MRI (metal, severe claustrophobia).
5. Diabetes mellitus type 1. History of severe head trauma, stroke, chemotherapy or brain surgery. Hypo- or hyperthyroidism. Epilepsy. Systemic glucocorticoid hormone treatment.
6. Other conditions interfering with participation according to the qualified physician's judgment.

Where it's running

• Aarhus University Hospital, Psychosis Research Unit
  Aarhus, Denmark Recruiting

Study contacts

• Study coordinator: Ole Köhler-Forsberg, MD, PhD, DMSc
• Email: karkoe@rm.dk
• Phone: 004578471610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.