NCT03943537CompletedPhase 2
Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 7 May 2019
- Start date
- 1 Oct 2019
- Primary completion date
- 23 Feb 2024
- Lead sponsor
- Mclean Hospital
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT03943537
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 87
- From 1 Oct 2019 to the primary completion date, 23 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Taking medication other than birth control
Other illness
- 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
- 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
- DSM diagnosis of substance use disorder in the past month
Other
- BMI \> 35 or body weight \> 350 lbs or BMI \<18
- For Healthy Controls:
Who the study is looking for
- 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)
Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.