Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
NCT03943537, Phase 2, Completed, Mclean Hospital; results first posted 2025-04-15
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders | ClinicalTrials.gov |
| NCT number | NCT03943537 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 87 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Mclean Hospital | ClinicalTrials.gov |
| Conditions | Psychosis, Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder | ClinicalTrials.gov |
| Interventions | Intranasal Insulin | ClinicalTrials.gov |
| First posted | 2019-05-09 | ClinicalTrials.gov |
| Last updated | 2026-09-03 | ClinicalTrials.gov |
| Results first posted | 2025-04-15 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Changes in Brain Redox State | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy | ClinicalTrials.gov |
| Primary | Changes in Brain ATP | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in ATP concentration as measured by in vivo 31P magnetic resonance spectroscopy | ClinicalTrials.gov |
| Primary | Changes in Brain PCr | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in Phosphocreatine (PCr) concentration as measured by in vivo 31P magnetic resonance spectroscopy | ClinicalTrials.gov |
| Primary | Changes in Brain CK | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy | ClinicalTrials.gov |
| Primary | Changes in STROOP Color-word Interference Score | 6 hours, pre- and post- 40 IU intranasal insulin | 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. | ClinicalTrials.gov |
| Primary | Changes in BACS Digit Sequencing Score | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in BACS digit sequencing scores, ranging from 0 - 36. Higher scores indicate better cognitive function. | ClinicalTrials.gov |
| Primary | Changes in BACS Symbol Coding | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in BACS Symbol Coding test, with scores ranging from 0 - 110. Higher scores indicate better cognitive function. | ClinicalTrials.gov |
| Primary | Changes in BACS Verbal Fluency Scores | 6 hours, pre- and post- 40 IU intranasal insulin | 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. | ClinicalTrials.gov |
| Secondary | Changes in Brain pH. | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in pH as measured by in vivo 31P magnetic resonance spectroscopy | ClinicalTrials.gov |
| Secondary | Changes in Brain Inorganic Phosphate Concentration. | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in inorganic phosphate (Pi) concentration as measured by in vivo 31P magnetic resonance spectroscopy | ClinicalTrials.gov |
| Secondary | Change in Fasting Blood Glucose Levels. | 6 hours, pre- and post- 40 IU intranasal insulin | Safety outcome. | ClinicalTrials.gov |
| Secondary | Change in Fasting Blood Insulin Levels. | 6 hours, pre- and post- 40 IU intranasal insulin | Safety outcome. | ClinicalTrials.gov |
| Secondary | Change in Brain Glutamate Concentration | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in glutamate (Glu) concentration as measured by in vivo proton magnetic resonance spectroscopy | ClinicalTrials.gov |
| Secondary | Changes in Brain Glutamine Concentration | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in glutamine (Gln) concentration as measured by in vivo proton magnetic resonance spectroscopy | ClinicalTrials.gov |
| Secondary | Changes in Brain Glutathione Concentration | 6 hours, pre- and post- 40 IU intranasal insulin | Changes in glutathione (GSH) concentration as measured by in vivo proton magnetic resonance spectroscopy | ClinicalTrials.gov |
Outcomes 15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Changes in Brain Redox State | 6 hours, pre- and post- 40 IU intranasal insulin | ratio | MEAN | ClinicalTrials.gov | |
| PRIMARY | Changes in Brain ATP | 6 hours, pre- and post- 40 IU intranasal insulin | mM | MEAN | ClinicalTrials.gov | |
| PRIMARY | Changes in Brain PCr | 6 hours, pre- and post- 40 IU intranasal insulin | mM | MEAN | ClinicalTrials.gov | |
| PRIMARY | Changes in Brain CK | 6 hours, pre- and post- 40 IU intranasal insulin | s^-1 | MEAN | ClinicalTrials.gov | |
| PRIMARY | Changes in STROOP Color-word Interference Score | 6 hours, pre- and post- 40 IU intranasal insulin | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Changes in BACS Digit Sequencing Score | 6 hours, pre- and post- 40 IU intranasal insulin | score on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Changes in BACS Symbol Coding | 6 hours, pre- and post- 40 IU intranasal insulin | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Changes in BACS Verbal Fluency Scores | 6 hours, pre- and post- 40 IU intranasal insulin | z-score | MEAN | ClinicalTrials.gov | |
| SECONDARY | Changes in Brain pH. | 6 hours, pre- and post- 40 IU intranasal insulin | pH | MEAN | ClinicalTrials.gov | |
| SECONDARY | Changes in Brain Inorganic Phosphate Concentration. | 6 hours, pre- and post- 40 IU intranasal insulin | mM | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change in Fasting Blood Glucose Levels. | 6 hours, pre- and post- 40 IU intranasal insulin | mg/dL | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change in Fasting Blood Insulin Levels. | 6 hours, pre- and post- 40 IU intranasal insulin | uIU/mL | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change in Brain Glutamate Concentration | 6 hours, pre- and post- 40 IU intranasal insulin | mM | MEAN | ClinicalTrials.gov | |
| SECONDARY | Changes in Brain Glutamine Concentration | 6 hours, pre- and post- 40 IU intranasal insulin | mM | MEAN | ClinicalTrials.gov | |
| SECONDARY | Changes in Brain Glutathione Concentration | 6 hours, pre- and post- 40 IU intranasal insulin | mM | MEAN | ClinicalTrials.gov |
Results by group 30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Changes in Brain Redox State | Patients | -0.269 | 95% Confidence Interval -0.769 to 0.231 | ratio | ClinicalTrials.gov | |
| Changes in Brain Redox State | Controls | -0.485 | 95% Confidence Interval -1.077 to 0.107 | ratio | ClinicalTrials.gov | |
| Changes in Brain ATP | Patients | 0.017 | 95% Confidence Interval -0.121 to 0.154 | mM | ClinicalTrials.gov | |
| Changes in Brain ATP | Controls | 0.119 | 95% Confidence Interval -0.006 to 0.244 | mM | ClinicalTrials.gov | |
| Changes in Brain PCr | Patients | 0.013 | 95% Confidence Interval -0.030 to 0.056 | mM | ClinicalTrials.gov | |
| Changes in Brain PCr | Controls | -0.033 | 95% Confidence Interval -0.070 to 0.005 | mM | ClinicalTrials.gov | |
| Changes in Brain CK | Patients | 0.009 | 95% Confidence Interval -0.012 to 0.029 | s^-1 | ClinicalTrials.gov | |
| Changes in Brain CK | Controls | 0.006 | 95% Confidence Interval -0.012 to 0.025 | s^-1 | ClinicalTrials.gov | |
| Changes in STROOP Color-word Interference Score | Patients | 1.11 | 95% Confidence Interval -0.38 to 2.61 | score on a scale | ClinicalTrials.gov | |
| Changes in STROOP Color-word Interference Score | Controls | 0.94 | 95% Confidence Interval -0.14 to 2.01 | score on a scale | ClinicalTrials.gov | |
| Changes in BACS Digit Sequencing Score | Patients | 0.05 | 95% Confidence Interval -0.35 to 0.45 | score on a scale | ClinicalTrials.gov | |
| Changes in BACS Digit Sequencing Score | Controls | 0.16 | 95% Confidence Interval -0.20 to 0.51 | score on a scale | ClinicalTrials.gov | |
| Changes in BACS Symbol Coding | Patients | 0.74 | 95% Confidence Interval 0.37 to 1.11 | units on a scale | ClinicalTrials.gov | |
| Changes in BACS Symbol Coding | Controls | 0.83 | 95% Confidence Interval 0.58 to 1.09 | units on a scale | ClinicalTrials.gov | |
| Changes in BACS Verbal Fluency Scores | Patients | 0.22 | 95% Confidence Interval -0.07 to 0.50 | z-score | ClinicalTrials.gov | |
| Changes in BACS Verbal Fluency Scores | Controls | 0.43 | 95% Confidence Interval 0.14 to 0.72 | z-score | ClinicalTrials.gov | |
| Changes in Brain pH. | Patients | 0 | 95% Confidence Interval -0.007 to 0.007 | pH | ClinicalTrials.gov | |
| Changes in Brain pH. | Controls | -0.004 | 95% Confidence Interval -0.012 to 0.003 | pH | ClinicalTrials.gov | |
| Changes in Brain Inorganic Phosphate Concentration. | Patients | -0.002 | 95% Confidence Interval -0.022 to 0.017 | mM | ClinicalTrials.gov | |
| Changes in Brain Inorganic Phosphate Concentration. | Controls | -0.020 | 95% Confidence Interval -0.044 to 0.005 | mM | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Patients | 41 | ClinicalTrials.gov | |
| Overall Study | STARTED | Controls | 46 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Patients | 21 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Controls | 18 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Patients | 20 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Controls | 28 | ClinicalTrials.gov |
Adverse events 4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Nasal irritation | Skin and subcutaneous tissue disorders | Patients | 0 | 21 | ClinicalTrials.gov | |
| other | Nasal irritation | Skin and subcutaneous tissue disorders | Controls | 1 | 18 | ClinicalTrials.gov | |
| other | Headache with nausea after insulin administration | Nervous system disorders | Patients | 0 | 21 | ClinicalTrials.gov | |
| other | Headache with nausea after insulin administration | Nervous system disorders | Controls | 1 | 18 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Patients | 0 | 21 | ClinicalTrials.gov |
| Total, all-cause mortality | Controls | 0 | 18 | ClinicalTrials.gov |
| Total, other adverse events | Patients | 0 | 21 | ClinicalTrials.gov |
| Total, other adverse events | Controls | 2 | 18 | ClinicalTrials.gov |
| Total, serious adverse events | Patients | 0 | 21 | ClinicalTrials.gov |
| Total, serious adverse events | Controls | 0 | 18 | ClinicalTrials.gov |
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Patients vs Controls: deaths from any cause | Trial comparisons |
| Patients vs Controls: serious adverse events | Trial comparisons |
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)