← 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

All Individual Drugs Already Approved

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effort-Expenditure for Rewards Task (EEfRT)

Secondary study objectives

Digit Symbol Substitution Test (DSST)

International Physical Activity Questionnaire (IPAQ)

Montgomery-Asberg Depression Scale (MADRS)

+9 more

Other study objectives

Addiction Severity Index (ASI)

Blood Pressure (mmHG)

Childhood Trauma Questionnaire- CTQ

+6 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

0 / 5Eligibility criteria met