Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders

NCT03943537 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2019P000664
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is a single center, single dose study of the acute effects of intranasal insulin on energy metabolism and cognitive function in patients with schizophrenia, schizoaffective and bipolar disorders, compared and healthy controls.

Conditions

Psychosis; Schizophrenia; Schizo Affective Disorder; Bipolar I Disorder

Keywords

Psychosis; Insulin; Brain Metabolism; Cognition

Outcome Measures

Primary Outcomes (8)

• Changes in Brain Redox State

  Changes in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy

  6 hours, pre- and post- 40 IU intranasal insulin

• Changes in Brain ATP

  Changes in ATP concentration as measured by in vivo 31P magnetic resonance spectroscopy

  6 hours, pre- and post- 40 IU intranasal insulin

• Changes in Brain PCr

  Changes in Phosphocreatine (PCr) concentration as measured by in vivo 31P magnetic resonance spectroscopy

  6 hours, pre- and post- 40 IU intranasal insulin

• Changes in Brain CK

  Changes in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy

  6 hours, pre- and post- 40 IU intranasal insulin

• Changes in STROOP Color-word Interference Score

  Changes in STROOP assessment color-word condition interference score. This score is calculated as follows, with C being the number of items answered correctly in the color condition, W being the number answered correctly in the word condition, and CW being the number of items answered correctly in the color-word condition: CW - (C x W)/(C+W). Higher scores indicate better cognitive function.

  6 hours, pre- and post- 40 IU intranasal insulin

• Changes in BACS Digit Sequencing Score

  Changes in BACS digit sequencing scores, ranging from 0 - 36. Higher scores indicate better cognitive function.

  6 hours, pre- and post- 40 IU intranasal insulin

• Changes in BACS Symbol Coding

  Changes in BACS Symbol Coding test, with scores ranging from 0 - 110. Higher scores indicate better cognitive function.

  6 hours, pre- and post- 40 IU intranasal insulin

• Changes in BACS Verbal Fluency Scores

  Changes in BACS verbal fluency subscale z-scores, measured by number of words generated over 60-second trials. A z-score of 0 indicates the population mean. Higher scores indicate better cognitive function.

  6 hours, pre- and post- 40 IU intranasal insulin

Secondary Outcomes (7)

• Changes in Brain pH.

  6 hours, pre- and post- 40 IU intranasal insulin

• Changes in Brain Inorganic Phosphate Concentration.

  6 hours, pre- and post- 40 IU intranasal insulin

• Change in Fasting Blood Glucose Levels.

  6 hours, pre- and post- 40 IU intranasal insulin

• Change in Fasting Blood Insulin Levels.

  6 hours, pre- and post- 40 IU intranasal insulin

• Change in Brain Glutamate Concentration

  6 hours, pre- and post- 40 IU intranasal insulin

Study Arms (1)

Intranasal Insulin (40 IU)

EXPERIMENTAL

40 IU Novolin-R insulin will be administered one time using the ViaNase intranasal delivery device.

Drug: Intranasal Insulin

Interventions

Intranasal Insulin DRUG

40 units Novolin R administered intranasally using ViaNase device.

Also known as: Novolin R

Intranasal Insulin (40 IU)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Insulin Resistance

Interventions

Insulin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Virginie-Anne Chouinard
• Organization: McLean Hospital

vchouinard@mclean.harvard.edu

617-855-3034

Study Officials

• Virginie-Anne Chouinard, M.D.

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychiatrist, Schizophrenia and Bipolar Disorder Research Program

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: October 1, 2019
• Primary Completion: February 23, 2024
• Study Completion: February 23, 2024
• Last Updated: April 15, 2025
• Results First Posted: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)