Intranasal Insulin and Olanzapine Study in Healthy Volunteers

Launched by CENTRE FOR ADDICTION AND MENTAL HEALTH · Nov 9, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called olanzapine, often used to treat mental health conditions, and intranasal insulin, which is delivered through the nose, in healthy volunteers. The researchers want to understand how these substances affect glucose levels in the body and cognitive functions, like memory and thinking ability. They hope to find out if intranasal insulin can help lower glucose production and improve cognitive performance, and if olanzapine might interfere with these effects.

To participate, you need to be a healthy adult between the ages of 17 and 65, and you should not have any history of psychiatric illness or diabetes. Participants will undergo various tests, including a procedure to measure how their body handles glucose, and some may have brain scans using MRI to see how these treatments affect brain activity. This trial is important because it aims to better understand the metabolic side effects of antipsychotic medications and explore potential treatments that could improve cognitive health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy non-obese volunteers
• • Age: 17 to 45 (Cognitive Arm) OR Ages 17-65 (Metabolic Arm)
• Exclusion Criteria:
• • History of current or past psychiatric illness (according to the Mini International Neuropsychiatric Interview \[MINI\]).\[As an exception for the Metabolic Arm only, anxiety disorders will not be exclusionary (including, but not limited to: agoraphobia, social anxiety disorder, generalized anxiety disorder, and panic disorder)\].
• • Left-handedness (only for the cognitive and MRI arm)
• • Pre-diabetes or diabetes (fasting glucose ≥6.0mmol/L or use of anti-diabetic drug);
• • Evidence of impaired glucose tolerance on screening OGTT
• • Family history of diabetes
• • Use of weight reducing agents or other medications based on the discretion of the PI
• • History of liver disease or AST\> 2 times upper limit of normal
• • History of kidney disease
• • Major medical or surgical event within the last 6 months
• • Any condition that interferes with safe acquisition of MRI data such as metal implants, pacemakers, cochlear implants, claustrophobia, etc. (only for the cognitive and MRI component)
• • Pregnancy and/or breastfeeding