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

StatusActive, Not Recruiting
PhaseNot applicable
Started2023-04-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 1, 2026 → Dec 31, 2026
See other at-risk trials from Centre for Addiction and Mental Health

Amendment history

2026-09-26
notable
Enrollment closed, study ongoing
Primary completion pushed: 2026-08-01 → 2026-12-31
Completion pushed: 2026-08-01 → 2026-12-31
2026-05-26
minor
Study Status, Oversight v4
Primary completion date2026-04-01→2026-08-01
Completion date2026-04-01→2026-08-01
2025-07-31
minor
Study Status, Oversight, Study Description, Eligibility v3
Primary completion date2025-04-01→2026-04-01
Completion date2025-04-01→2026-04-01
Eligibility criteria-279 characters
Inclusion Criteria: i) Experimental group (participants with a diagnosis of schizophrenia spectrum disorder): Antipsychotic naïve or antipsychotic treatment for equal to or less than 3 weeks within the past 3 months (Medications can be confirmed via CAMH chart review). Participants do not need to remain off of antipsychotics for the duration of the study. 17-45 years both sexes; Patients with first-episode schizoph [...] confirmed via CAMH chart review). BMI under or equal to 27 Right-handed ii) Control group (healthy controls): 17-45 years of age sex-, hand dominance (right-handed) -and body mass i [...] [...]
Study description-66 characters
[...] nsulin action is a feature of SCZ. The study examines young antipsychotic-naïve/free SCZ patients to minimize medication-related confounds. Insulin (160 IU; shown to be safe and effective previously [...]
2024-08-19
minor
Study Status v2
Re-verified, no change to tracked fields
2024-01-11
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sites0→1
2023-02-28
minor
Original filing
Cognitive impairment (such as challenges in thinking and memory) is a core aspect of schizophrenia (SCZ), contributing to disability and poor functional outcomes. Additionally, almost half of the patients with SCZ are obese, the prevalence of type 2 diabetes is 3-6 times higher, and life expectancy is lower by 15-20 years compared to the general population. This is relevant as metabolic syndrome and diabetes are both associated with worse cognition among SCZ patients. Recent work studying the relationships between metabolic health and cognition has encouraged a new way of thinking about SCZ as both a metabolic and cognitive disorder. Brain insulin is involved in several processes relevant to SCZ, and abnormal brain insulin action may help explain both cognitive and metabolic abnormalities in patients with SCZ, but this has not been examined previously. Glucose uptake in several brain regions relevant to SCZ has been shown to be partially dependent on insulin. Therefore, in this study, the researchers will measure glucose uptake in the brain using an 18F-fluorodeoxyglucose (\[18F\]-FDG) positron emission tomography (PET) scan after an intranasal insulin stimulus, and will compare this measure between patients with SCZ and healthy controls.
Trial Details
NCT Number NCT05748990
Lead Sponsor Centre for Addiction and Mental Health
Conditions Schizophrenia, Healthy
Enrollment 20 participants
Start Date 2023-04-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-25