PsychosisPhase 2NCT03943537
Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
A Phase 2 study testing Intranasal Insulin in people with Psychosis and Schizophrenia, run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Schizophrenia, Schizo Affective Disorder
- What is being tested?
- Intranasal Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 23 Feb 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Psychotic disorders are common and severe psychiatric disorders. Despite advances in understanding the pathophysiology of these disorders, more effective and tolerable treatments are still needed. Evidence suggests that energy metabolism is altered in psychotic disorders. The investigators recently developed non-invasive MRI-based techniques to quantify redox balance and ATP generation in the brain. Targeting insulin pathways in the brain may allow for modulating abnormalities in energy metabolism. The investigators seek to examine whether intranasal insulin can modulate energy metabolism and improve cognition in patients with psychotic disorders. The study will use magnetic resonance spectroscopy (MRS) technology to measure in vivo energy metabolism processes in the brain, before and after the administration of intranasal insulin. Investigators will also measure changes in cognition with the administration of intranasal insulin.
- Being tested
- Intranasal Insulin
- Keywords
- Psychosis, Insulin, Brain Metabolism, Cognition
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal InsulinDrug
Also called Novolin R
40 units Novolin R administered intranasally using ViaNase device.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Insulin (40 IU) | Experimental | 40 IU Novolin-R insulin will be administered one time using the ViaNase intranasal delivery device. Receives: Drug: Intranasal Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Brain Redox State
Changes in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 hours, pre- and post- 40 IU intranasal insulin
Secondary outcomes (7)
Changes in Brain pH.
Changes in pH as measured by in vivo 31P magnetic resonance spectroscopy
Measured: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in Brain Inorganic Phosphate Concentration.
Changes in inorganic phosphate (Pi) concentration as measured by in vivo 31P magnetic resonance spectroscopy
Measured: 6 hours, pre- and post- 40 IU intranasal insulin
Change in Fasting Blood Glucose Levels.
Safety outcome.
Measured: 6 hours, pre- and post- 40 IU intranasal insulin
Change in Fasting Blood Insulin Levels.
Safety outcome.
Measured: 6 hours, pre- and post- 40 IU intranasal insulin
Change in Brain Glutamate Concentration
Changes in glutamate (Glu) concentration as measured by in vivo proton magnetic resonance spectroscopy
Measured: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in Brain Glutamine Concentration
Changes in glutamine (Gln) concentration as measured by in vivo proton magnetic resonance spectroscopy
Measured: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in Brain Glutathione Concentration
Changes in glutathione (GSH) concentration as measured by in vivo proton magnetic resonance spectroscopy
Measured: 6 hours, pre- and post- 40 IU intranasal insulin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Oct 2019
- Primary completion23 Feb 2024
- Study completion23 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virginie-Anne Chouinard, MD, Mclean Hospital
- Investigators
- Virginie-Anne Chouinard, M.D., Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943537
- Sponsor's protocol ID
- 2019P000664
- Status last verified
- Apr 2025
- First submitted
- 7 May 2019
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No