Brain Insulin Resistance in Mood Disorders
Major Depressive Disorder, Bipolar Disorder, Anhedonia
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion criteria (patients):
- Age 18-50
- DSM-5 defined MDD/BD and a total score ≥20 on the Montgomery-Åsberg Depression Rating Scale (MADRS) and no history of dementia or intellectual disability
- A written, voluntary informed consent prior to study enrollment
Exclusion criteria (patients):
- Use of insulin and/or oral hypoglycemiants, due to its confounding effects
- Diagnosis of possible or probable AD, MCI, or any other dementia
- History of neurological disorder, or evidence of neurologic or other physical illness that could produce cognitive deterioration
- Substance use disorder within 3 months before screening or a positive baseline toxicology screen
- Presence of clinically unstable general medical illness
- Pregnancy or breastfeeding
- MRI contraindications
Inclusion criteria (healthy controls):
- Age 18-50
- A written, voluntary informed consent prior to study enrollment
Exclusion criteria (healthy controls):
- Use of insulin and/or oral hypoglycemiants, due to its confounding effects
- Presence of any current or lifetime psychiatric or neurological conditions
- Substance use disorder within 3 months before screening or a positive baseline toxicology screen
- Presence of clinically unstable general medical illness
- Pregnancy or breastfeeding
- MRI contraindications
Sites / Locations
- Toronto Western HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Insulin
Sterile Diluent
Intranasal insulin will be made prepared from Humulin® R [insulin injection, human biosynthetic (rDNA Origin) REGULAR; 10 mL/vial, manufactured by Eli Lilly]. Each mL contains: 100 units of insulin injection, human biosynthetic (rDNA Origin) REGULAR. Nonmedicinal ingredients contain: glycerol, hydrochloric acid, m-cresol, sodium hydroxide and water for injection. Unopened vials should be stored under refrigeration between 2°C and 8°C (36°F to 46°F) until the expiration date; do not freeze; keep away from heat and sunlight. Once punctured (in use), Humulin vials should be stored at room temperature <25°C (<77°F) and discarded after 28 days. To obtain a dose Humulin R 160 U / placebo 16 sprays (0.1 mL/spray) are to be given per dose This works out to 16 sprays split between each nostril such that each nostril receives 8 sprays. The sprays will be administered between alternating nostrils
Intranasal placebo will be prepared from Eli Lilly's sterile diluent used with Humulin® R (10 mL/vial, manufactured by Eli Lilly). Nonmedicinal ingredients contain: dibasic sodium phosphate, glycerin, liquefied phenol, metacresol, hydrochloric acid, sodium hydroxide and water for injection. Unused sterile diluent should be kept at controlled room temperature until the expiration date. The USP defines controlled room temperature as (20° to 25°C [68° to 77°F]), with excursions permitted (15° to 30°C [59° to 86°F]). Once in-use, the sterile diluent vial should be used within 28 days. Participants will follow the same dosage, frequency, and administration as Humulin: 16 sprays (0.1 mL/spray) are to be given per dose This works out to 16 sprays split between each nostril such that each nostril receives 8 sprays. The sprays will be administered between alternating nostrils