Haloperidol for Brain Insulin Sensitivity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the medication haloperidol affects insulin's role in the brain. Insulin, a hormone that helps control sugar levels, can influence brain function. Researchers aim to determine if haloperidol, an antipsychotic drug, disrupts insulin's brain activity, potentially leading to side effects like weight gain or diabetes. Participants will take haloperidol or a placebo (a look-alike pill with no active ingredient) at night for a week. Individuals without a history of psychiatric illness, diabetes, or irregular menstrual cycles might be suitable for this trial. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients.
Will I have to stop taking my current medications?
The trial requires that you stop using certain medications, including hormonal birth control and any drugs that affect blood sugar levels. If you're taking painkillers or antihistamines, these need to be reviewed by the study's principal investigator.
What is the safety track record for haloperidol?
Research shows that haloperidol often treats mental health conditions like schizophrenia and bipolar disorder. With its long history of use, extensive information exists about its safety. Most people tolerate it well, but some side effects require attention. The most common side effects include movement problems, sometimes called muscle control issues.
Haloperidol can also cause weight gain and affect insulin use in the body, potentially increasing diabetes risk. This is crucial because the study examines how haloperidol affects insulin in the brain. In this Phase 4 trial, researchers build on existing knowledge, indicating a solid understanding of the drug's safety.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for brain insulin sensitivity, which often involve lifestyle changes and medications like metformin or pioglitazone, haloperidol offers a novel approach by potentially improving insulin sensitivity through its unique mechanism as an antipsychotic. Researchers are excited because haloperidol, typically used for psychiatric conditions, may influence dopamine pathways that indirectly affect insulin regulation in the brain. This could open up new avenues for treating insulin resistance, especially in cases where typical metabolic treatments fall short. Additionally, the short administration period of just 7 days could mean faster insights into its effectiveness compared to traditional therapies.
What evidence suggests that haloperidol might affect brain insulin sensitivity?
Research shows that haloperidol, a medication for mental health conditions, can affect insulin function in the brain. Insulin, a hormone, helps control blood sugar levels. Studies have found that haloperidol can impair the brain's ability to detect sugar, leading to reduced insulin effectiveness in the body. This may result in higher blood sugar levels. While haloperidol treats conditions like schizophrenia and bipolar disorder, it may also alter metabolism, causing weight gain and increasing diabetes risk. Understanding these effects is crucial for managing the long-term risks of antipsychotic medications. Participants in this trial will receive either haloperidol or a placebo to further investigate these effects on brain insulin sensitivity.56789
Who Is on the Research Team?
Mahavir Agarwal, MBBS, MD, PhD
Principal Investigator
Centre for Addiction and Mental Health
Are You a Good Fit for This Trial?
This trial is for healthy individuals who can help researchers understand how the antipsychotic medication haloperidol affects insulin action in the brain. The study seeks to explore potential metabolic risks associated with this drug.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive haloperidol or placebo for 7 days to assess its effect on insulin action in the brain
Follow-up
Participants are monitored for metabolic and cognitive outcomes, including glucose levels, insulin resistance, and cognitive tests
What Are the Treatments Tested in This Trial?
Interventions
- Haloperidol
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre for Addiction and Mental Health
Lead Sponsor
The Physicians' Services Incorporated Foundation
Collaborator