Centre for Addiction and Mental Health
Toronto, Ontario, M6J 1H3, Canada
Location status: Recruiting
NCT Number: NCT07109245
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.
Interested in participating?
Request Info18 year–35 year
All sexes
Interventional
Phase 4
Toronto, Ontario, M6J 1H3, Canada
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Oral placebo, encapsulated and to be taken at an equivalent titration schedule to Haloperidol.
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
A total of 1.6 mL of intranasal saline will be administered on each MRI scanning visit (0.8 mL delivered per nostril).
Time frame: From enrollment to the end of study will be up to 5 months
Resting state functional connectivity (rsFC) between the anterior cingulate cortex of the salience network and the lateral parietal cortex of the default mode network (DMN) will be assessed through a MRI-based assay. Calculated using the correlation between two brain regions' blood-oxygen-level-dependent (BOLD) signal times.
Time frame: From enrollment to the end of study will be up to 5 months
Weight (kg) and Height (cm) will be aggregated to BMI (kg/m^2) at screening and MRI scanning visits.
Time frame: From enrollment to the end of study will be up to 5 months
Waist Circumference (cm) collected at screening and MRI scanning visits.
Time frame: From enrollment to the end of study will be up to 5 months
Glucose (mmol/L), will be measured at 2 time points on each MRI scanning day, pre- and post-intranasal insulin challenge.
Time frame: From enrollment to the end of study will be up to 5 months
Insulin (uIU/mL), will be measured at screening and at 2 time points on each MRI scanning day, pre- and post-intranasal insulin challenge.
Time frame: From enrollment to the end of study will be up to 5 months
C-peptide (nmol/L), will be measured at screening and 2 time points on each MRI scanning day, pre- and post-intranasal insulin challenge.
Time frame: From enrollment to the end of study will be up to 5 months
HbA1c (mmol/mol), will be measured at screening and 2 time points on each MRI scanning day, pre- and post-intranasal insulin challenge
Time frame: From enrollment to the end of study will be up to 5 months
HOMA-IR, will be measured at 2 time points on each MRI scanning day, pre- and post-intranasal insulin challenge. HOMA-IR = (Fasting Insulin (uIU/mL) * Fasting Glucose (mmol/L)) / 22.5
Time frame: From enrollment to the end of study will be up to 5 months
Plasma antipsychotic (haloperidol) levels will be measured with concentrations expressed in nanograms per millilitre (ng/mL). Collected on each MRI scanning day.
Time frame: From enrollment to the end of study will be up to 5 months
The Stanford Sleepiness Scale (SSS), which is a self-reported scale (scale of 1-7), where higher scores indicate greater sedation. Administered on each MRI scanning visit.
Time frame: From enrollment to the end of study will be up to 5 months
The Digit Symbol Substitution Test (DSST), which will be reported as the number of correct responses (count per 90 seconds), where lower scores reflect greater sedation or cognitive slowing. Administered on each MRI scanning day.
Time frame: From enrollment to the end of study will be up to 5 months
The Barnes Akathisia Scale (BAS) (scale of 0-14), with higher scores indicating more severe akathisia. Administered on each MRI scanning day.
Time frame: From enrollment to the end of study will be up to 5 months
The Simpson-Angus Scale (SAS) (scale of 0-40), where higher values indicate more pronounced parkinsonian symptoms. Administered on each MRI scanning day.
Time frame: From enrollment to the end of study will be up to 5 months
Abnormal Involuntary Movement Scale (AIMS) (scale of 0-42), with higher scores corresponding to more severe involuntary movements. Administered on each MRI scanning day.
Time frame: From enrollment to the end of study will be up to 5 months
Side effects will be assessed using the UKU Side Effect Rating Scale, which will be reported as a scale score (scale of 0-144), where higher scores indicate a greater burden of side effects. Administered on each MRI scanning day.
Contact information is provided by the study sponsor or research team.
Mahavir Agarwal, MBBS, MD, PhD
CONTACT
416-535-8501 ext. 30546
Maria Papoulias, MSc
CONTACT
416-535-8501 ext. 39365
Centre for Addiction and Mental Health
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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