Actively Recruiting
Keto-Brain: Cerebral Energy Metabolism in First-Episode Schizophrenia
Led by Ole Köhler-Forsberg · Updated on 2025-12-30
34
Participants Needed
1
Research Sites
2 weeks
Total Duration
On this page
Sponsors
O
Ole Köhler-Forsberg
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying brain energy use in people newly diagnosed with first-episode schizophrenia (FES) who have not yet taken antipsychotic medications. The study aims to understand how the brain metabolizes ketones and glucose by comparing these patients to healthy volunteers using PET scans. This observational study includes clinical assessments and follows patients through their initial antipsychotic treatment to monitor changes in brain metabolism. Participants with FES will undergo PET neuroimaging before starting antipsychotic treatment and again after 4 to 8 weeks of treatment. Healthy control participants will have a single baseline PET scan. Patients will receive standard clinical care at their local psychiatric hospital, which is not affected by study participation. The study includes a follow-up clinical visit 6 months after the initial assessment. During the study, participants will complete interviews and questionnaires assessing symptoms, cognition, and general health. Vital signs and body measurements will be recorded. Safety monitoring is conducted by local clinicians following usual care guidelines. Researchers will measure brain ketone and glucose metabolism changes using PET scans and track clinical symptoms, cognitive function, and treatment response over time. The study will last from 2025 to 2027.
CONDITIONS
Brief Title
KetoBrain: Brain Energy Metabolism in Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 35 years
- Diagnosed with first-episode schizophrenia (ICD-10: F20)
- Able to give informed oral and written consent
- For healthy controls: Age 18 to 35 years
- For healthy controls: No mental disorder (ICD-10: F00-99)
- For healthy controls: Able to give informed oral and written consent
You will not qualify if you...
- Any coercive measures including forensic psychiatry patients
- Unable to attend the research study as evaluated by the treating clinician
- Previous use of antipsychotics at doses higher than specified low doses exceeding 2 weeks in the past year or 6 weeks lifetime
- Use of antipsychotics in the last 3 months above specified low doses
- Comorbid borderline intelligence, intellectual disability, autism spectrum disorder, active substance use disorder, or psychosis due to medical or drug causes
- Pregnancy, childbirth within past 6 months, or breastfeeding without effective contraception
- Contraindications to MRI such as metal implants or severe claustrophobia
- Acute suicidal thoughts requiring hospitalization
- Diabetes mellitus type 1, history of severe head trauma, stroke, chemotherapy, brain surgery, thyroid disorders, epilepsy, or systemic glucocorticoid treatment
- Other conditions interfering with participation per physician judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At enrollment
Participants undergo baseline PET scans to measure whole brain ketone and glucose metabolism.
1 baseline visit (in-person)
Duration - 4 to 8 weeks
Participants with first-episode schizophrenia are observed for changes in brain metabolism after 4 to 8 weeks of antipsychotic treatment.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital, Psychosis Research Unit
Aarhus, Denmark
Actively Recruiting
Research Team
O
Ole Köhler-Forsberg, MD, PhD, DMSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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