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Brain insulin study aims to uncover why antipsychotics cause weight gain

NCT ID NCT03741478

Knowledge-focused Sponsor: Centre for Addiction and Mental Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how the antipsychotic drug olanzapine changes the way the brain responds to insulin, which may explain why these drugs often lead to weight gain and diabetes. Healthy volunteers will receive olanzapine or placebo, along with insulin nasal spray, and undergo tests of glucose metabolism and memory. The goal is to understand the brain's role in these side effects, not to treat any disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Olanzapine and intranasal insulin
What this could lead to
If successful, this study could clarify how antipsychotics cause metabolic side effects like weight gain and diabetes, potentially leading to safer treatments.
What could go wrong
This is a small, early-phase study in healthy volunteers, not patients. Results may not apply to people with mental illness, and the findings are exploratory.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 64 people

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

Started

Oct 2019

Expected to finish

Jul 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: * Healthy non-obese volunteers * Age: 17 to 45 (Cognitive Arm) OR Ages 17-65 (Metabolic Arm) Exclusion Criteria: * History of current or past psychiatric illness (according to the Mini International Neuropsychiatric Interview \[MINI\]).\[As an exception for the Metabolic Arm only, anxiety disorders will not be exclusionary (including, but not limited to: agoraphobia, social anxiety disorder, generalized anxiety disorder, and panic disorder)\]. * Left-handedness (only for the cognitive and MRI arm) * Pre-diabetes or diabetes (fasting glucose ≥6.0mmol/L or use of anti-diabetic drug); * Evidence of impaired glucose tolerance on screening OGTT * Family history of diabetes * Use of weight reducing agents or other medications based on the discretion of the PI * History of liver disease or AST\> 2 times upper limit of normal * History of kidney disease * Major medical or surgical event within the last 6 months * Any condition that interferes with safe acquisition of MRI data such as metal implants, pacemakers, cochlear implants, claustrophobia, etc. (only for the cognitive and MRI component) * Pregnancy and/or breastfeeding

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy controls

Contacts and locations

Locations

  • Center for Addiction and Mental Health

    Toronto, Ontario, M5T 1R8, Canada

  • University Health Network - Toronto General Hospital

    Toronto, Ontario, M5G 2C4, Canada

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