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Could insulin in the brain be linked to depression in teens?

NCT ID NCT05571878

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study examined 24 adolescents (ages 14-18) with and without depression to see if their brains respond differently to insulin. Participants received insulin or a placebo nasal spray, and MRI scans measured brain activity and blood flow. The goal was to understand if brain insulin resistance is a feature of depression, which could open new avenues for future treatments.

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) and saline placebo nasal spray
What this could lead to
If it works, this could reveal a new biological link between insulin and depression, pointing toward future treatments targeting brain metabolism.
What could go wrong
This is a small pilot study with only 24 participants, so results may not apply broadly. It is designed to gather knowledge, not to test a 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

24 people

The number who actually took part.

Started

Sep 2021

Finished

May 2025

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

14 to 18 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: * Age 14- 18 * One of the following: Diagnosis of Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD); or score ≥22 on the Mood and Feeling Questionnaire and confirmation of depression with the Mini International Neuropsychiatric Interview Kid (MINI Kid) * BMI between 5-95th population percentile and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≤2.5 calculated using fasting blood work values (glucose and insulin) Exclusion Criteria: * History of primary psychotic illness * Use of antipsychotics or mood stabilizers * History of current substance use disorder (moderate to severe) * Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol/l or use of anti-diabetic drug) * Evidence of impaired glucose tolerance on screening oral glucose tolerance test (OGTT) * Use of weight, lipids, or blood pressure reducing agents * History of liver disease or AST\>2 times upper limit of normal * History of kidney disease * MRI contraindications * Positive pregnancy test * Allergic to exogenous insulin * Positive result on urine drug screen (participants with positive cannabis and alcohol urine drug screens may still be eligible for the study; positive drug screens for other substances will be exclusionary)

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder dysthymic disorder Insulin Resistance major depressive disorder type 2 diabetes mellitus

As listed by the trial registrant

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

Depression Major depressive disorder

Contacts and locations

Locations

  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H3, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.