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Brain insulin may hold key to schizophrenia's cognitive fog

NCT ID NCT05748990

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

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

17 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Insulin Resistance schizophrenia

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Centre for Addiction and Mental Health

    RECRUITING

    Toronto, Ontario, M6J1H3, Canada

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