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Study identifier: NCT07309172 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

KetoBrain: Brain Energy Metabolism in Schizophrenia

Condition: Schizophrenia Disorder  ·  Sponsor: Ole Köhler-Forsberg

PhaseN/A
Planned participants34
Who can joinAll sexes, 18 Years to 35 Years
Healthy volunteersYes

About this study

Objective The objective is to recruit antipsychotic-naïve patients at the first diagnosis with a first-episode schizophrenia disorder (FES) to study ketone metabolism of the brain via PET neuroimaging. Participants will undergo PET neuroimaging at baseline before start of antipsychotic treatment and after 4-8 weeks of antipsychotic treatment including an additional clinical follow-up visit after 6 months. In addition, a healthy control group with one baseline visit will be recruited. Study design Non-interventional neuroimaging study with pre-defined follow-up visits. Patients Patients with a FES (ICD-10: F20) aged 18-35 years who are antipsychotic-naïve including age- and sex-matched healthy controls. Sample size This is an observational pilot project. Currently, no studies have measured brain ketone metabolism before and after AP intake. Assuming a 50% dropout rate at follow-up, the investigators aim to recruit 22 patients to obtain 12 full datasets - a sample size commonly used in PET studies. Healthy controls will only have one study day, so no dropouts are expected - aiming at a sample size of 12 healthy controls. Procedures Patients will be included at the first FES diagnosis. Before inclusion, an interview with the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) interview will validate the diagnosis. At baseline and follow-up (details in the full protocol and Table 1), patients will be rated by use of the 6-item Positive and Negative Syndrome Scale (PAN…

This description comes directly from the study's public registry record.

Talk to the study team

Ole Köhler-Forsberg, MD, PhD, DMSc  ·  004578471610  ·  karkoe@rm.dk

Always discuss trial participation with your own doctor first.

Locations (1)

Aarhus University Hospital, Psychosis Research UnitAarhus, DenmarkRecruiting

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Source record: clinicaltrials.gov/study/NCT07309172