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Effects of Antipsychotics on Brain Insulin Action in Females

StatusActive, Not Recruiting
PhaseNot applicable
Started2024-06-03
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 1, 2026 → Dec 31, 2026
See other at-risk trials from Centre for Addiction and Mental Health

Amendment history

2026-09-29
notable
Enrollment closed, study ongoing
Primary completion pushed: 2026-08-01 → 2026-12-31
Completion pushed: 2026-08-01 → 2026-12-31
2026-03-26
minor
Study Status v2
Primary completion date2026-03-01→2026-08-01
Completion date2026-03-01→2026-08-01
2024-07-31
minor
Study Status, Study Description, Eligibility v1
Start dateestimated 2024-02-28→confirmed 2024-06-03
Eligibility criteria+403 characters
Inclusion Criteria: Age: 18-35 years Body Mass Index (BMI) <25between 18.5 - 24.9 kg/m2 Right-handed Normal menstrual cycle (defined as cycle length ranging from [...] eostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥12.85; Family history of diabetes in a first degree relative; (parent or sibling) Use of weight reducing agents; History of kidney or liver d [...] mplants, pacemakers, cochlear implants, claustrophobia, etc. Any contraindications to the investigational products as listed in the product monographs including known hypersensitivity to the drug or the excipients of the product (note: en [...]
Study description+15 characters
[...] ognition. In a proof-of-concept neuroimaging study at CAMH, wethe investigators investigated AP-induced brain IR using an INI challenge. As [...]
2024-02-01
minor
Original filing
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.
Trial Details
NCT Number NCT06251635
Lead Sponsor Centre for Addiction and Mental Health
Conditions Insulin Resistance, Menstrual Cycle, Type 2 Diabetes, Antipsychotics
Enrollment 15 participants
Start Date 2024-06-03
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-28