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Brain insulin may hold key to schizophrenia's cognitive fog
NCT ID NCT05748990
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study investigates whether abnormal insulin action in the brain contributes to cognitive and metabolic problems in schizophrenia. Twenty participants (some with schizophrenia, some healthy) will receive either intranasal insulin or a placebo before a PET scan that measures brain glucose uptake. The goal is to see if brain insulin resistance is linked to thinking and memory challenges in schizophrenia.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intranasal insulin (Humalog)
- What this could lead to
- If successful, this could reveal a link between brain insulin resistance and cognitive problems in schizophrenia, pointing toward new treatment targets.
- What could go wrong
- This is a very small, early-stage study (20 people) that only measures brain activity, not clinical outcomes. It may not lead to any treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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17 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centre for Addiction and Mental Health
RECRUITINGToronto, Ontario, M6J1H3, Canada
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