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Can a nasal insulin spray rev up brain energy and sharpen thinking in psychosis?

NCT ID NCT03943537

Disease control Sponsor: Mclean Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether a single dose of insulin given through the nose can change how the brain produces energy and improve thinking in people with psychotic disorders like schizophrenia, schizoaffective disorder, or bipolar disorder with psychosis. Researchers will compare these patients with healthy controls, using brain scans to measure energy-related molecules and cognitive tests to assess attention, memory, and verbal fluency. The goal is to see if boosting brain energy metabolism with insulin might help counteract the cognitive difficulties often seen in these conditions.

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 (Novolin R)
What this could lead to
If it works, this could point toward a new way to improve thinking and memory in people with schizophrenia, schizoaffective disorder, or bipolar disorder with psychosis.
What could go wrong
This is an early, single-dose study in a small group, so any benefits may be short-lived or not appear at all. The trial focuses on brain energy markers and cognitive tests, not long-term outcomes.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

87 people

The number who actually took part.

Started

Oct 2019

Finished

Feb 2024

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

18 to 40 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: * Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses of schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features OR * Healthy Controls (no history of DSM psychiatric diagnoses, nor history of the same in first-degree relatives) Exclusion Criteria: * Psychiatric hospitalization within the last 4 weeks * Unstable/active disease or potential contraindications, such as liver disease, kidney disease, uncontrolled hypertension, significant or unstable medical illness * Currently prescribed: antidiabetic agents, including oral antidiabetic medications and insulin, intranasal medication, steroids, weight loss agents * Pregnant or breast-feeding, not using an effective form of contraception for at least 3 months, and/or not abstinent for 1 month prior to enrollment * History of significant head injury * Contraindication to MRI scans (claustrophobia, cardiac pacemakers, metal clips and stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings, other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal patches, metal-containing IUDs). * Medical conditions preventing blood draws * History of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within the last 3 months * BMI \> 35 or body weight \> 350 lbs or BMI \<18 * DSM diagnosis of substance use disorder in the past month * For Healthy Controls: * Taking medication other than birth control

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Conditions

The condition(s) this trial relates to.

bipolar I disorder Insulin Resistance psychotic disorder Psychotic Disorders schizoaffective disorder schizophrenia

As listed by the trial registrant

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

Bipolar I disorder Psychosis Schizo affective disorder Schizophrenia

Contacts and locations

Locations

  • McLean Hospital

    Belmont, Massachusetts, 02478, United States

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