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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study 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 belowSelect...
I am 18-50 years old with major depression or bipolar disorder, scoring ≥20 on the MADRS, and no dementia or intellectual disability.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
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 moreOther outcome measures
Addiction Severity Index (ASI)
Blood Pressure (mmHG)
Childhood Trauma Questionnaire- CTQ
+6 moreTrial 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
1,475 Previous Clinical Trials
484,940 Total Patients Enrolled
54 Trials studying Depression
12,150 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not use insulin or oral medications for blood sugar control.I am between 18-50 years old and agree to participate in the study.I am 18-50 years old with major depression or bipolar disorder, scoring ≥20 on the MADRS, and no dementia or intellectual disability.I am healthy but have a serious ongoing illness.I have a neurological disorder or illness that could affect my thinking.You have struggled with drug or alcohol addiction in the past three months, or have tested positive for drugs during screening.People without medical conditions that prevent them from having an MRI.Healthy people who are pregnant or breastfeedingI am not using insulin or oral medications for blood sugar control.You have a serious medical condition that is not stable.I have no history of psychiatric or neurological conditions.You are not eligible if you have used drugs or alcohol heavily in the past 3 months or have a positive drug test.You are unable to have an MRI scan for medical reasons.I have been diagnosed with Alzheimer's, mild cognitive impairment, or another form of dementia.
Research Study Groups:
This trial has the following groups:- Group 1: Insulin
- Group 2: Sterile Diluent
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for me to participate in this trial?
"This clinical trial is recruiting 150 individuals suffering from manic disorder, who are between 18 and 50 years old. Candidates must meet the following requirements: DSM-5 defined MDD/BD with a total score on the Montgomery-Åsberg Depression Rating Scale (MADRS) of 20 or higher, absent history of dementia, no intellectual disabilities and voluntary written informed consent before enrolment."
Answered by AI
What other experiments have been conducted to explore the potential of Humulin R?
"Currently, 71 trials are being conducted to research Humulin R. Of these investigations 13 have reached the third phase of testing. Most studies for this treatment occur in Wilmington, Delaware, yet other sites across 247 cities and towns also partake in its exploration."
Answered by AI
What is the cap on patient participation in this medical investigation?
"Affirmative. Clinicaltrials.gov data confirms that this medical study, which was initially posted on October 6th 2021, is presently seeking participants. Approximately 150 individuals need to be recruited from a single clinical site."
Answered by AI
Is the eligibility for this clinical trial confined to individuals under fifty years of age?
"This medical research is seeking participants aged 18 or above, but under 50 years old."
Answered by AI
Is enrollment still open for this research initiative?
"Per clinicaltrials.gov, this trial is actively recruiting participants and was initially published on October 6th 2021 with no edits made since then."
Answered by AI
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