← Back to Search

Hormone Therapy

Intranasal Insulin for Mood Disorders

Phase 1 & 2
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients aged 18-50 with 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
Be between 18 and 65 years old
Must not have
Healthy controls with presence of clinically unstable general medical illness
Patients with history of neurological disorder, or evidence of neurologic or other physical illness that could produce cognitive deterioration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Summary

This trial is studying how well insulin works in treating anhedonia in people with mood disorders.

Who is the study for?
This trial is for adults aged 18-50 with Major Depressive Disorder or Bipolar Disorder, who are experiencing anhedonia and have a depression score indicating moderate to severe symptoms. Healthy participants without psychiatric/neurological conditions can also join. Exclusions include pregnancy, breastfeeding, insulin/hypoglycemic use, substance abuse within the last 3 months, unstable medical illnesses, MRI contraindications, and cognitive impairments.Check my eligibility
What is being tested?
The study aims to understand how insulin affects brain function related to pleasure and reward in mood disorders. It involves taking intranasal insulin (Humulin R) or a placebo (Diluent), measuring body responses like metabolism and BMI, brain activity via fMRI during tasks testing effort for rewards, and assessing behavior using clinical scales.See study design
What are the potential side effects?
Intranasal Humulin R may cause local irritation or allergic reactions at the site of administration. Systemic side effects could include low blood sugar levels if absorbed systemically. However as this is not common with intranasal delivery compared to injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18-50 years old with major depression or bipolar disorder, scoring ≥20 on the MADRS, and no dementia or intellectual disability.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am healthy but have a serious ongoing illness.
Select...
I have a neurological disorder or illness that could affect my thinking.
Select...
I am not using insulin or oral medications for blood sugar control.
Select...
I have no history of psychiatric or neurological conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effort-Expenditure for Rewards Task (EEfRT)
Secondary outcome measures
Digit Symbol Substitution Test (DSST)
International Physical Activity Questionnaire (IPAQ)
Montgomery-Asberg Depression Scale (MADRS)
+9 more
Other outcome measures
Addiction Severity Index (ASI)
Blood Pressure (mmHG)
Childhood Trauma Questionnaire- CTQ
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InsulinExperimental Treatment1 Intervention
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
Group II: Sterile DiluentPlacebo Group1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Insulin human
FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,492 Previous Clinical Trials
489,894 Total Patients Enrolled
54 Trials studying Depression
12,150 Patients Enrolled for Depression

Media Library

Humulin R (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03915613 — Phase 1 & 2
Depression Research Study Groups: Insulin, Sterile Diluent
Depression Clinical Trial 2023: Humulin R Highlights & Side Effects. Trial Name: NCT03915613 — Phase 1 & 2
Humulin R (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03915613 — Phase 1 & 2
~9 spots leftby Oct 2024