Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Feb 28, 2023

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ClinConnect Summary

This clinical trial is investigating how insulin action in the brain may affect thinking and metabolic health in people with schizophrenia. Cognitive issues, such as problems with memory and concentration, are common in individuals with schizophrenia, and many also face serious health challenges like obesity and diabetes. Researchers want to understand if abnormal insulin function in the brain could be linked to these cognitive and metabolic difficulties. To do this, they will use a special brain scan to see how glucose (a type of sugar the body uses for energy) is taken up in the brain after giving participants a dose of insulin through their nose. They will compare the results from people with schizophrenia to those from healthy individuals.

To be part of the study, participants with schizophrenia should be between 17 and 45 years old, either not taking any antipsychotic medications or having taken them for a short time recently. They also need to have a body mass index (BMI) of 27 or less and be right-handed. Healthy volunteers who meet similar age, sex, and BMI criteria are also welcome to join. Participants can expect to undergo a brain scan and may contribute valuable information that could help improve understanding of schizophrenia and its related health issues. It's important for potential participants to know that there are specific health conditions that would exclude them from the study, such as diabetes or certain neurological disorders.

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Eligibility criteria

• Inclusion Criteria:
• i) Experimental group (participants with a diagnosis of schizophrenia spectrum disorder):
• • 1. 17-45 years
• • 2. both sexes;
• • 3. Patients with first-episode schizophrenia spectrum illness: Primary DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, psychotic disorder NOS, major depressive disorder with psychotic symptoms, bipolar I disorder, and bipolar II disorder, OR substance-induced psychosis, and antipsychotic treatment for schizophrenia, schizoaffective disorder, or other specified schizophrenia spectrum, other psychotic disorder, major depressive disorder with psychotic symptoms, bipolar I disorder, and bipolar II. (Diagnosis willbe confirmed via CAMH chart review).
• • 4. BMI under or equal to 27
• ii) Control group (healthy controls):
• • 1. 17-45 years of age
• • 2. sex-,
• • 3. hand dominance -and
• • 4. body mass index (BMI)-matched
• • 5. Absence of DSM-5 diagnosis other than a specific phobia according to MINI
• Exclusion Criteria:
• • 1. moderate or severe substance use according to MINI (per PI discretion in the case of moderate alcohol or cannabis use)
• • 2. prediabetes, diabetes, or evidence of impaired glucose tolerance on screening OGTT
• • 3. acute suicidal risk
• • 4. use of weight, lipid, antidiabetic or blood pressure reducing agents
• • 5. liver or kidney disease
• • 6. pregnancy
• • 7. nursing
• • 8. pacemakers
• • 9. metallic cardiac valves
• • 10. magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude the MRI scan
• • 11. clinically significant claustrophobia (determined from MRI screening form; significance evaluated as per QI's discretion).
• • 12. history of head trauma resulting in loss of consciousness \> 30 minutes that required medical attention;
• • 13. size of head, neck, precluding to fit in the MRI or PET scanners
• • 14. weight over 350lbs (limit for MRI scanner bed)
• • 15. unstable physical illness
• • 16. significant neurological disorder including a seizure disorder;
• • 17. Received maximum allowed radiation in the past 12 months (20 mSv)
• • 18. Completed more than 6 PET scans/ lifetime, that, together with the PET scanning procedures under this protocol will bring the total number of PET scans to more than the allowed/lifetime (8 PET scans per lifetime). These limits are set by the Centre for Addiction and Mental Health Brain Health Imaging Centre Guideline.
• • 19. clinically relevant abnormality observed in medical history,
• • 20. current intake of any medication that may interfere with participation in the study or may confound the results of PET imaging (e.g. anti-diabetic medication).
• • 21. Disorders of coagulation, blood or ongoing use of anticoagulant medication
• Control group: Exclusionary criteria are as listed above for participants, in addition to:
• • 1) First degree family member with primary psychotic disorder.