Recruiting

Haloperidol

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT07109245

Conditions

Brain Insulin Sensitivity

Healthy Controls

Cognition

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Haloperidol

Placebo

Insulin Lispro

Saline

Study Details

Brief 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

Study ID

NCT07109245

Start date

Dec 11, 2025

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Must be deemed to have the capacity to provide informed consent
2. Must sign and date the informed consent form
3. Stated willingness to comply with all study procedures;
4. Age: 18-35
5. Body Mass Index (BMI) 18.5-24.9 kg/m2
6. Both sexes

Exclusion Criteria:

1. History of psychiatric illness, including any substance use (screened using the Mini International Neuropsychiatric Interview (MINI))
2. Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol/L, HbA1c>6% or use of anti-diabetic drug),
3. Evidence of impaired insulin sensitivity, assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥2.5
4. Family history of diabetes in a first degree relative (parent or sibling)
5. Use of weight reducing agents
6. History of kidney or liver disease
7. History of cell blood disorders
8. 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)
9. 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 \[50\]
10. Current use of progesterone, estrogen, testosterone, or fertility treatment.
11. Pregnant, gave birth in the last year, or breastfeeding. Participants must have at least 3 regular menstrual cycles post-breastfeeding before beginning the study.
12. Major medical or surgical event within the last 6 months
13. Contraindications for MRI, including metal implants, pacemakers, cochlear implants, claustrophobia, weight >250 lbs
14. 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),
15. Any medications that increases risk of hypoglycemia or could contribute to hyperglycemia
16. Any medical conditions that constitute as a warning/precaution for haloperidol, lorazepam, benztropine, or insulin.
17. Use of any of the prohibited medications listed in the product monograph of haloperidol, lorazepam, benztropine, or insulin (Pheochromocytoma, barbiturates, and narcotics are exclusionary, any use of painkillers and antihistamines must be reviewed by PI but are not exclusionary

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: Placebo

Placebo capsules, visually identical to those containing haloperidol, will be administered according to the same dosing schedule

Interventions

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.

Placebo

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

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

Saline

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

Primary outcome measure

  • RsFC between the anterior cingulate cortex of the salience network and the lateral parietal cortex of the DMN [ Time Frame: From enrollment to the end of study will be up to 5 months ]
  • Metabolic Outcome: BMI [ Time Frame: From enrollment to the end of study will be up to 5 months ]
  • Metabolic Outcome: Waist Circumference [ Time Frame: From enrollment to the end of study will be up to 5 months ]
  • Metabolic Outcome: Glucose [ Time Frame: From enrollment to the end of study will be up to 5 months ]
  • Metabolic Outcome: Insulin [ Time Frame: From enrollment to the end of study will be up to 5 months ]
  • Metabolic Outcome: C-peptide [ Time Frame: From enrollment to the end of study will be up to 5 months ]
  • Metabolic Outcome: HbA1c [ Time Frame: From enrollment to the end of study will be up to 5 months ]
  • Metabolic Outcome: HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) [ Time Frame: From enrollment to the end of study will be up to 5 months ]

Central Contacts and Locations

Central contacts

Mahavir Agarwal, MBBS, MD, PhD

416-535-8501mahavir.agarwal@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J 1H3

Contacts

Mahavir Agarwal, MBBS, MD, PhD

416-535-8501mahavir.agarwal@camh.ca

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Keywords

  • Brain Insulin Sensitivity
  • Healthy Control Study
  • Haloperidol
  • Cognition
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-04-02.