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Study identifier: NCT06251635 Synced from ClinicalTrials.gov · July 28, 2026
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Effects of Antipsychotics on Brain Insulin Action in Females

Condition: Insulin Resistance · Menstrual Cycle · Type 2 Diabetes  ·  Sponsor: Centre for Addiction and Mental Health

PhaseNA
Planned participants15
Who can joinFemale, 18 Years to 35 Years
Healthy volunteersYes

About this study

Females treated with antipsychotics have higher rates of comorbid metabolic syndrome than males. Despite this, females have historically been excluded from many mechanistic studies due to confounding effects of menstrual cycles. Recent evidence suggests that brain insulin resistance may be an underlying mechanism through which antipsychotics may exert their metabolic side effects. This study seeks to investigate how brain insulin action differs in females according to their menstrual cycle phase, and how a high metabolic liability agent such as olanzapine might interrupt these differential insulin effects. Young healthy females will be given olanzapine and intranasal insulin to test how these treatment combinations change brain processes. Participants will be tested during both the first half of their menstrual cycle (follicular phase) and the second half of their cycle (luteal phase). The investigators predict that intranasal insulin will change MRI-based measures in females, in a comparable way to males, in the follicular phase only. Adding olanzapine will block these effects of insulin in females in the follicular phase. This investigation has the potential to generate new knowledge in an area of significant unmet need. Demonstrating that antipsychotics disrupt brain insulin action, evidenced by inhibition of recognized effects of insulin on neuroimaging measures, will provide novel insights into currently poorly understood mechanisms.

This description comes directly from the study's public registry record.

Talk to the study team

Mahavir Agarwal, MBBS, PhD  ·  4165358501  ·  mahavir.agarwal@camh.ca

Maria Papoulias  ·  4165358501  ·  maria.papoulias@camh.ca

Always discuss trial participation with your own doctor first.

Locations (1)

Centre for Addiction and Mental Health (CAMH)Toronto, Ontario, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT06251635