McLean Hospital
Belmont, Massachusetts, 02478, United States
NCT Number: NCT03943537
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.
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Notify Me18 year–40 year
All sexes
Interventional
Phase 2
Belmont, Massachusetts, 02478, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
40 units Novolin R administered intranasally using ViaNase device.
Other names: Novolin R
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in brain NAD+/NADH ratio as measured by in vivo 31P magnetic resonance spectroscopy
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in ATP concentration as measured by in vivo 31P magnetic resonance spectroscopy
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in Phosphocreatine (PCr) concentration as measured by in vivo 31P magnetic resonance spectroscopy
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in pH as measured by in vivo 31P magnetic resonance spectroscopy
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in inorganic phosphate (Pi) concentration as measured by in vivo 31P magnetic resonance spectroscopy
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Safety outcome.
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Safety outcome.
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in glutamate (Glu) concentration as measured by in vivo proton magnetic resonance spectroscopy
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in glutamine (Gln) concentration as measured by in vivo proton magnetic resonance spectroscopy
Time frame: 6 hours, pre- and post- 40 IU intranasal insulin
Changes in glutathione (GSH) concentration as measured by in vivo proton magnetic resonance spectroscopy
Mclean Hospital
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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