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

Not Applicable

Recruiting

• Conditions: Schizophrenia; Healthy

• Registration Number: NCT05748990
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-2-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br>i) Experimental group (participants with a diagnosis of schizophrenia spectrum disorder):<br><br> 1. Antipsychotic naïve or antipsychotic treatment for equal to or less than 3 weeks<br> within the past 3 months<br><br> 2. (Medications can be confirmed via CAMH chart review). Participants do not need to<br> remain off of antipsychotics for the duration of the study.<br><br> 3. 17-45 years<br><br> 4. both sexes;<br><br> 5. Patients with first-episode schizophrenia spectrum illness: Primary DSM-5 diagnosis<br> of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional<br> disorder, brief psychotic disorder, psychotic disorder NOS, major depressive<br> disorder with psychotic symptoms, bipolar I disorder, and bipolar II disorder, OR<br> substance-induced psychosis, and antipsychotic treatment for schizophrenia,<br> schizoaffective disorder, or other specified schizophrenia spectrum, other psychotic<br> disorder, major depressive disorder with psychotic symptoms, bipolar I disorder, and<br> bipolar II. (Diagnosis willbe confirmed via CAMH chart review).<br><br> 6. BMI under or equal to 27<br><br> 7. Right-handed<br><br>ii) Control group (healthy controls):<br><br> 1. 17-45 years of age<br><br> 2. sex-,<br><br> 3. hand dominance (right-handed) -and<br><br> 4. body mass index (BMI)-matched<br><br> 5. Absence of DSM-5 diagnosis other than a specific phobia according to MINI<br><br>Exclusion Criteria:<br><br> 1) moderate or severe substance use according to MINI (per PI discretion in the case of<br> moderate alcohol or cannabis use)<br><br> 1. prediabetes, diabetes, or evidence of impaired glucose tolerance on screening OGTT<br><br> 2. acute suicidal risk<br><br> 3. use of weight, lipid, antidiabetic or blood pressure reducing agents<br><br> 4. liver or kidney disease<br><br> 5. pregnancy<br><br> 6. nursing<br><br> 7. pacemakers<br><br> 8. metallic cardiac valves<br><br> 9. magnetic material such as surgical clips, implanted electronic infusion pumps or any<br> other conditions that would preclude the MRI scan<br><br> 10. clinically significant claustrophobia (determined from MRI screening form;<br> significance evaluated as per QI's discretion).<br><br> 11. history of head trauma resulting in loss of consciousness > 30 minutes that required<br> medical attention;<br><br> 12. size of head, neck, precluding to fit in the MRI or PET scanners<br><br> 13. weight over 350lbs (limit for MRI scanner bed)<br><br> 14. unstable physical illness<br><br> 15. significant neurological disorder including a seizure disorder;<br><br> 16. Received maximum allowed radiation in the past 12 months (20 mSv)<br><br> 17. Completed more than 6 PET scans/ lifetime, that, together with the PET scanning<br> procedures under this protocol will bring the total number of PET scans to more than<br> the allowed/lifetime (8 PET scans per lifetime). These limits are set by the Centre<br> for Addiction and Mental Health Brain Health Imaging Centre Guideline.<br><br> 18. clinically relevant abnormality observed in medical history,<br><br> 19. current intake of any medication that may interfere with participation in the study<br> or may confound the results of PET imaging (e.g. anti-diabetic medication).<br><br> 20. Disorders of coagulation, blood or ongoing use of anticoagulant medication<br><br>Control group: Exclusionary criteria are as listed above for participants, in addition<br>to:<br><br> 1) First degree family member with primary psychotic disorder.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[18F]-FDG brain uptake