Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?

Summary

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

• Brain Insulin Sensitivity
• Healthy Controls
• Cognition

Interventions

DRUG

Haloperidol

The oral investigational agent haloperidol (Generic Brand: TEVA-HALOPERIDOL) will be self-administered, at night, over 7 days. Haloperidol will be titrated up to 2 mg.

DRUG

Placebo

Oral placebo, encapsulated and to be taken at an equivalent titration schedule to Haloperidol.

DRUG

Insulin Lispro

A total of 160 IU of intransal insulin (=1.6 mL) will be administered on MRI scanning visits (80 IU = 0.8 mL delivered per nostril). Humalog; Eli Lilly Canada

OTHER

Saline

A total of 1.6 mL of intranasal saline will be administered on each MRI scanning visit (0.8 mL delivered per nostril).

Sponsors & Collaborators

• The Physicians' Services Incorporated Foundation

  collaborator OTHER

• Centre for Addiction and Mental Health

  lead OTHER

Principal Investigators

• Mahavir Agarwal, MBBS, MD, PhD · Centre for Addiction and Mental Health

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-11

Primary Completion

2028-08-31

Completion

2028-12-31

Countries

• Canada

Study Locations