Actively Recruiting
Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?
Led by Centre for Addiction and Mental Health · Updated on 2026-04-02
35
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
C
Centre for Addiction and Mental Health
Lead Sponsor
T
The Physicians' Services Incorporated Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study aimed at helping researchers understand how a medication called haloperidol can affect insulin action in the brain. Insulin is a hormone in the body that controls sugar levels in part by lowering the amount of glucose produced by the liver. After eating a meal, insulin levels go up in both the blood and the brain. Insulin in the brain has also been shown to affect the way the brain works and processes information (also known as "cognition"). Haloperidol, is an antipsychotic medication used to treat a variety of disorders such as schizophrenia spectrum disorders, bipolar disorder, and major depressive disorder, but long-term use can have metabolic side effects, like weight gain, type 2 diabetes, and cardiovascular disease. The purpose of this study is to investigate how antipsychotic medications, such as haloperidol, which carries the risk of metabolic changes, might interrupt the effect of insulin action in the brain. This will help researchers learn how to potentially reduce metabolic risk for people who take these kinds of medications in the future.
CONDITIONS
Official Title
Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be able to give informed consent
- Must sign and date the informed consent form
- Willingness to follow all study procedures
- Age between 18 and 35 years
- Body Mass Index (BMI) between 18.5 and 24.9 kg/m2
- Both sexes eligible
You will not qualify if you...
- History of psychiatric illness or substance use
- Diagnosis of pre-diabetes or diabetes, or use of anti-diabetic drugs
- Impaired insulin sensitivity (HOMA-IR 2.5)
- Family history of diabetes in a parent or sibling
- Use of weight-reducing agents
- History of kidney or liver disease
- History of blood cell disorders
- Irregular menstrual cycles or certain reproductive health conditions
- Current use of hormonal birth control or hormonal treatments
- Pregnant, gave birth in last year, or breastfeeding without 3 regular cycles post-breastfeeding
- Major medical or surgical event in last 6 months
- Contraindications for MRI (metal implants, pacemakers, claustrophobia, weight over 250 lbs)
- Known allergies to study drugs or their ingredients
- Use of medications increasing risk of low or high blood sugar
- Medical conditions cautioning use of haloperidol, lorazepam, benztropine, or insulin
- Use of prohibited medications listed in haloperidol product monograph
AI-Screening
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Trial Site Locations
Total: 1 location
1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H3
Actively Recruiting
Research Team
M
Mahavir Agarwal, MBBS, MD, PhD
CONTACT
M
Maria Papoulias, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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