Investigating how antipsychotics affect brain insulin action in women
Effects of Antipsychotics on Brain Insulin Action in Females: A Randomised Placebo-Controlled, Crossover Multi-Modal Neuroimaging Study
This study is testing how the antipsychotic olanzapine affects brain insulin action in young women during different phases of their menstrual cycle to better understand its metabolic side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | Female |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06251635 on ClinicalTrials.gov |
What this trial studies
This study examines the effects of antipsychotics, specifically olanzapine, on brain insulin action in young healthy females across different phases of their menstrual cycle. Participants will receive olanzapine and intranasal insulin to assess changes in brain processes using MRI. The study aims to understand how menstrual cycle phases influence brain insulin resistance and the metabolic side effects of antipsychotic treatment. By focusing on females, who are disproportionately affected by metabolic issues related to antipsychotics, the research seeks to fill a significant gap in understanding these effects.
Who should consider this trial
Good fit: Ideal candidates are young healthy females aged 18-35 with a normal menstrual cycle and a BMI between 18.5 and 24.9.
Not a fit: Patients with a history of psychiatric illness, pre-diabetes, diabetes, or irregular menstrual cycles may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for women taking antipsychotics, potentially reducing their risk of metabolic syndrome.
How similar studies have performed: While there is preliminary evidence suggesting the effects of antipsychotics on brain insulin action, this specific approach focusing on menstrual cycle phases in females is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * History of psychiatric illness (screened using the Mini International Neuropsychiatric Interview (MINI)); * Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol/L, HbA1c\>6% or use of anti-diabetic drug); * Evidence of impaired insulin sensitivity, assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥2.5; * Family history of diabetes in a first degree relative (parent or sibling) * Use of weight reducing agents; * History of kidney or liver disease; * Moderate-to-severe substance use; * 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); * 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; * 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. * 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).
Where this trial is running
Toronto, Ontario
- Centre for Addiction and Mental Health (CAMH) — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Mahavir Agarwal, MBBS, PhD, MD — Centre for Addiction and Mental Health
- Study coordinator: Mahavir Agarwal, MBBS, PhD
- Email: mahavir.agarwal@camh.ca
- Phone: 4165358501
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.