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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03943537
Other study ID # 2019P000664
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 1, 2019
Est. completion date January 26, 2024

Study information

Verified date December 2023
Source Mclean Hospital
Contact Jacey Anderson
Phone 617-855-3988
Email janderson75@mclean.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date January 26, 2024
Est. primary completion date January 26, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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, protease inhibitors, or NRTI's. - 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

Study Design


Intervention

Drug:
Intranasal Insulin
40 units Novolin R administered intranasally using ViaNase device.

Locations

Country Name City State
United States McLean Hospital Belmont Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in brain Gln, Glu and GSH Changes in glutamine (Gln), glutamate (Glu), and glutathione (GSH) concentration as measured by in vivo proton magnetic resonance spectroscopy 6 hours, pre- and post- 40 IU intranasal insulin
Primary Changes in brain redox state Changes in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy 6 hours, pre- and post- 40 IU intranasal insulin
Primary Changes in brain ATP Changes in ATP concentration as measured by in vivo 31P magnetic resonance spectroscopy 6 hours, pre- and post- 40 IU intranasal insulin
Primary Changes in brain PCr Changes in Phosphocreatine (PCr) concentration as measured by in vivo 31P magnetic resonance spectroscopy 6 hours, pre- and post- 40 IU intranasal insulin
Primary Changes in brain CK Changes in creatine kinase (CK) enzyme rate as measured by in vivo 31P magnetic resonance spectroscopy 6 hours, pre- and post- 40 IU intranasal insulin
Primary Changes in cognitive function 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. 6 hours, pre- and post- 40 IU intranasal insulin
Primary Changes in domain-specific cognitive function. Changes in BACS domain subscale scores (domain, range): working memory, 0-36; attention, 0-110; and verbal fluency, number of words generated over 60-sec trials. Higher scores indicate better cognitive function. 6 hours, pre- and post- 40 IU intranasal insulin
Secondary Changes in brain pH. Changes in pH as measured by in vivo 31P magnetic resonance spectroscopy 6 hours, pre- and post- 40 IU intranasal insulin
Secondary Changes in brain inorganic phosphate concentration. Changes in inorganic phosphate (Pi) concentration as measured by in vivo 31P magnetic resonance spectroscopy 6 hours, pre- and post- 40 IU intranasal insulin
Secondary Change in fasting blood glucose levels. Safety outcome. 6 hours, pre- and post- 40 IU intranasal insulin
Secondary Change in fasting blood insulin levels. Safety outcome. 6 hours, pre- and post- 40 IU intranasal insulin
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