Examining the effects of intranasal insulin and olanzapine in healthy volunteers
Effect of Antipsychotics on Central Insulin Action in Relation to Glucose Metabolism and Cognition in Healthy Volunteers
This study tests how a single dose of olanzapine affects blood sugar levels and thinking skills in healthy volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 17 Years to 45 Years |
| Sex | All |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT03741478 on ClinicalTrials.gov |
What this trial studies
This study investigates how a single dose of olanzapine affects glucose production and cognitive function in healthy volunteers. It features two parallel arms: one focusing on metabolic responses and the other on cognitive testing using MRI imaging techniques. The primary goal is to determine if olanzapine can inhibit insulin's effects on glucose production, while secondary objectives explore its impact on cognitive domains such as memory. The study aims to enhance understanding of the metabolic effects of antipsychotic medications.
Who should consider this trial
Good fit: Ideal candidates are healthy, non-obese individuals aged 17 to 65 without a history of psychiatric illness.
Not a fit: Patients with pre-diabetes, diabetes, or significant medical history may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into managing metabolic side effects associated with antipsychotic medications.
How similar studies have performed: While the specific approach of this study is novel, similar studies have explored the metabolic effects of antipsychotics with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario and 1 other locations
- University Health Network - Toronto General Hospital — Toronto, Ontario, Canada (Active_not_recruiting)
- Center for Addiction and Mental Health — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Margaret K Hahn, PhD, MD — Centre for Addiction and Mental Health
- Study coordinator: Margaret K Hahn, PhD, MD
- Email: margaret.hahn@camh.ca
- Phone: 416-535-8501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.