Schizophrenia Clinical Trial
Official title:
Effects of Intranasal Insulin on Neuroimaging Markers and Cognition in Patients With Psychotic Disorders
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 | 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 |
Country | Name | City | State |
---|---|---|---|
United States | McLean Hospital | Belmont | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Mclean Hospital |
United States,
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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