Testing Haloperidol with Insulin Lispro against a placebo for brain insulin sensitivity

Exclusion

• −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),
• −History of psychiatric illness, including any substance use (screenedScreeningThe checks done before joining, to see whether a study fits.Read more → using the Mini International Neuropsychiatric Interview (MINI))
• −Pre-diabetes or diabetes (fasting glucose ≥6.0 mmol/L, HbA1c\>6% or use of anti-diabetic drug),
• −Evidence of impaired insulin sensitivity, assessed using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) ≥2.5
• −Family history of diabetes in a first degree relative (parent or sibling)
• −Use of weight reducing agents
• −History of kidney or liver disease
• −History of cell blood disorders
• −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)
• −Current use of hormonal birth controlControl groupThe group a new treatment is measured against.Read more → (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 \[50\]
• −Current use of progesterone, estrogen, testosterone, or fertility treatment.
• −Major medical or surgical event within the last 6 months
• −Contraindications for MRI, including metal implants, pacemakers, cochlear implants, claustrophobia, weight \>250 lbs
• −Any medications that increases risk of hypoglycemia or could contribute to hyperglycemia
• −Any medical conditions that constitute as a warning/precaution for haloperidol, lorazepam, benztropine, or insulin.
• −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 PIPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → but are not exclusionary
• −Pregnant, gave birth in the last year, or breastfeeding. Participants must have at least 3 regular menstrual cycles post-breastfeeding before beginning the study.