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Hormone Therapy

Intranasal Insulin for Schizophrenia

Phase 2
Recruiting
Led By Virginie-Anne Chouinard, M.D.
Research Sponsored by Mclean Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 hours, pre- and post- 40 iu intranasal insulin
Awards & highlights

Study Summary

This trial is studying the effects of intranasal insulin on energy metabolism and cognitive function in people with schizophrenia, schizoaffective disorder, and bipolar disorder, compared to healthy controls.

Who is the study for?
This trial is for adults with schizophrenia, schizoaffective or bipolar disorder with psychotic features, and healthy individuals without psychiatric diagnoses. Excluded are those recently hospitalized for mental illness, with unstable diseases like liver or kidney disease, on certain medications including antidiabetics and steroids, pregnant or not using contraception effectively, have significant head injury history or contraindications to MRI scans.Check my eligibility
What is being tested?
The study tests the immediate effects of a single dose of intranasal insulin on brain energy metabolism and cognitive function in patients with specific psychotic disorders versus healthy controls. It's conducted at one center and includes neuroimaging to observe changes.See study design
What are the potential side effects?
While the trial description does not specify side effects of intranasal insulin, common ones may include irritation inside the nose, sneezing, runny nose; systemic side effects are less likely due to limited absorption into the bloodstream.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 hours, pre- and post- 40 iu intranasal insulin
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 hours, pre- and post- 40 iu intranasal insulin for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in brain ATP
Changes in brain CK
Body Weight Changes
+3 more
Secondary outcome measures
Change in fasting blood glucose levels.
Body Weight Changes
Changes in brain inorganic phosphate concentration.
+1 more
Other outcome measures
Changes in brain Gln, Glu and GSH

Side effects data

From 2016 Phase 2 trial • 26 Patients • NCT02028871
19%
Irritation
8%
Sweating
8%
Confusion
8%
Fainter Sniffin Sticks
4%
Anxiety
4%
Hunger
4%
Restlessness
4%
Uncomfortable
4%
Dizziness
4%
Fatigue
4%
Nasal Abrasions
4%
Eyes Watering
4%
Headache
4%
Tingling (mouth)
4%
Shaking
4%
Smell
4%
Sneezing
4%
Congestion
4%
Confined
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intranasal Insulin
Placebo
Follow up

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intranasal Insulin (40 IU)Experimental Treatment1 Intervention
40 IU Novolin-R insulin will be administered one time using the ViaNase intranasal delivery device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intranasal Insulin
2016
Completed Phase 3
~290

Find a Location

Who is running the clinical trial?

Mclean HospitalLead Sponsor
212 Previous Clinical Trials
21,504 Total Patients Enrolled
19 Trials studying Schizophrenia
1,332 Patients Enrolled for Schizophrenia
Virginie-Anne Chouinard, M.D.Principal InvestigatorMclean Hospital
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Intranasal Insulin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03943537 — Phase 2
Schizophrenia Research Study Groups: Intranasal Insulin (40 IU)
Schizophrenia Clinical Trial 2023: Intranasal Insulin Highlights & Side Effects. Trial Name: NCT03943537 — Phase 2
Intranasal Insulin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03943537 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
Virginie-Anne Chouinard, MD 2019. "Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03943537.
~16 spots leftby Apr 2025
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