Patients vs Controls: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0 | 0.155 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0 | 0 | 0.176 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0 | -0.176 | 0.155 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | ClinicalTrials.gov | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | ClinicalTrials.gov | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Patients | 21 patients with diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses of schizophrenia, schizoaffective disorder or bipolar disorder with psychotic features. All participants received 40 IU Novolin-R insulin administered one time using the ViaNase intranasal delivery device. | 0 | 21 | EG000 | ClinicalTrials.gov |
| Group 2 | Controls | 18 healthy Controls (no history of DSM psychiatric diagnoses, nor history of the same in first-degree relatives). All participants received 40 IU Novolin-R insulin administered one time using the ViaNase intranasal delivery device. | 0 | 18 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | Adverse events data were collected on the day of the intervention visit with one-time intranasal insulin administration. | ClinicalTrials.gov |
Trial 8
| 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 |
| Phases | PHASE2 | ClinicalTrials.gov |
| Conditions | Psychosis, Schizophrenia, Schizo Affective Disorder, Bipolar I Disorder | ClinicalTrials.gov |
| Interventions | Intranasal Insulin | ClinicalTrials.gov |
| Lead sponsor | Mclean Hospital | ClinicalTrials.gov |
| Results first posted | 2025-04-15 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT03943537?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
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. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.