Phase 2
N=87
Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
Psychosis · Schizophrenia · Schizo Affective Disorder · Bipolar I Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03943537 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Changes in Brain Redox State — -0.269; -0.485 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intranasal Insulin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mclean Hospital
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Brain Redox State |
-0.269; -0.485 | — |
| PRIMARY Changes in Brain ATP |
0.017; 0.119 | — |
| PRIMARY Changes in Brain PCr |
0.013; -0.033 | — |
| PRIMARY Changes in Brain CK |
0.009; 0.006 | — |
| PRIMARY Changes in STROOP Color-word Interference Score |
1.11; 0.94 | — |
| PRIMARY Changes in BACS Digit Sequencing Score |
0.05; 0.16 | — |
| PRIMARY Changes in BACS Symbol Coding |
0.74; 0.83 | — |
| PRIMARY Changes in BACS Verbal Fluency Scores |
0.22; 0.43 | — |
| SECONDARY Changes in Brain pH. |
0; -0.004 | — |
| SECONDARY Changes in Brain Inorganic Phosphate Concentration. |
-0.002; -0.020 | — |
| SECONDARY Change in Fasting Blood Glucose Levels. |
4.62; 2.17 | — |
| SECONDARY Change in Fasting Blood Insulin Levels. |
0.110; -0.228 | — |
| SECONDARY Change in Brain Glutamate Concentration |
-0.382; 0.475 | — |
| SECONDARY Changes in Brain Glutamine Concentration |
-0.110; 0.105 | — |
| SECONDARY Changes in Brain Glutathione Concentration |
-0.029; 0.148 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03943537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.