NCT06251635Active, not recruiting
Effects of Antipsychotics on Brain Insulin Action in Females
Effects of Antipsychotics on Brain Insulin Action in Females: A Randomised Placebo-Controlled, Crossover Multi-Modal Neuroimaging Study
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 1 Feb 2024
- Start date
- 3 Jun 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Centre for Addiction and Mental Health
- Diseases
- Type 2 diabetes
- NCT number
- NCT06251635
What you commit to
- Study type: Interventional
- Planned participants: 15
- From 3 Jun 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Irregular menstrual cycles (e.g., menstruation occurs less than 21 days or more than 35 days apart, or not having menstruated for three months (or 90 days), or conditions such as endometriosis or polycystic ovary syndrome (PCOS) or prior surgical interventions such as a hysterectomy or oophorectomy);
- Major medical or surgical event within the last 6 months;
- 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: enzymatic lactose intolerance is NOT exclusionary)
- Use of any of the prohibited medications listed in the product monograph of olanzapine (e.g., Levodopa and dopamine agonists and antihypertensive agents).
Other illness
- History of psychiatric illness (screened using the Mini International Neuropsychiatric Interview (MINI));
- Family history of diabetes in a first degree relative (parent or sibling)
- History of kidney or liver disease;
- Any condition that interferes with safe acquisition of MRI data such as metal implants, pacemakers, cochlear implants, claustrophobia, etc.
Lab values
- Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol/L, HbA1c\>6% or use of anti-diabetic drug);
Other
- Evidence of impaired insulin sensitivity, assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥2.5;
- Use of weight reducing agents;
- Moderate-to-severe substance use;
- Current use of hormonal birth control (e.g., pill, patch, hormonal intrauterine device \[IUD\], ring). Participants must have had at least 2 regular menstrual cycles following the discontinuation of hormonal birth control;
- Pregnant, gave birth in the last year, or breastfeeding. Participants must have at least 3 regular menstrual cycles post-breastfeeding before beginning the study;
- Current use of progesterone, estrogen, testosterone, or fertility treatment;
Who the study is looking for
- Age: 18-35 years
- Body Mass Index (BMI) between 18.5 - 24.9 kg/m2
- Normal menstrual cycle (defined as cycle length ranging from 21 to 35 days over the past 6 months).
Age in the registry: 18 years to 35 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre for Addiction and Mental Health (CAMH) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.