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Could a nasal insulin spray rewire the brain in psychosis?

NCT ID NCT07252752

Knowledge-focused Sponsor: Medical University of Vienna 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study investigates how insulin delivered through the nose changes dopamine signaling and energy use in the brains of people with first-episode psychosis. Researchers will compare brain scans and chemical levels in 46 participants (patients and healthy volunteers) after receiving insulin or a placebo. The goal is to understand the overlap between metabolic and psychiatric symptoms, not to treat the condition directly.

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
What this could lead to
If successful, this could reveal a link between insulin and dopamine in psychosis, pointing toward new treatment targets for schizophrenia.
What could go wrong
This is an early, small imaging study (46 people) that measures brain activity, not symptoms. It may not lead to any direct treatment or benefit for patients.

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 46 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

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

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: All participants * age 18-40 * Body mass index (BMI) range 18-25 * good general health according to physical examination and medical history * absence of relevant abnormalities in laboratory screening, electrocardiogram (ECG) or vital signs * no regular use of drugs of abuse or alcohol based on history and urine drug screen Patients only * diagnosis of schizophrenia or schizophreniform disorder according to DSM-5 * ability to give informed consent * minimum Positive and Negative Syndrome Scale (PANSS) score of 55 with \>3 on at least two or \>4 on one PANSS psychosis item Exclusion Criteria: All participants * severe or unstable medical or neurological illness or clinically significant abnormality on screening laboratory studies or ECG * established diagnosis of type 1 or type 2 diabetes * current substance use disorder or regular recreational drug abuse (except nicotine and caffeine) * pregnancy or breastfeeding * history of head trauma resulting in loss of consciousness of \>1min or requiring medical attention * presence of MRI exclusion criteria * if participation in this study would exceed annual radiation dose limits (30mSv) * clinically established diagnosis of intellectual disability Healthy volunteers only * Psychiatric disorder according to Mini-International Neuropsychiatric Interview (M.I.N.I.) * Schizophrenia or bipolar disorder in first degree family members Patients only ● Previous oral antipsychotic treatment for more than 2 weeks or previous treatment with antipsychotic depot preparation

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Conditions

The condition(s) this trial relates to.

schizophrenia schizophreniform disorder

As listed by the trial registrant

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

First episode psychosis (FEP)

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

  • Medical University of Vienna

    Vienna, 1090, Austria

More trials for these conditions

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