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Insulin
Insulin Therapy for Depression in Adolescents
N/A
Recruiting
Led By Mahavir Agarwal, MD, PhD
Research Sponsored by Centre for Addiction and Mental Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up peripheral insulin resistance: study visit 1, pre-mri #1 and post-mri #2, and 6-month follow-up study visit; brain insulin resistance: study visit 1, during mri scan #1 and #2
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if major depressive disorder in humans is linked to brain insulin resistance, using MRI measures to check for brain insulin action. The study will use adolescents as participants, as MDD typically starts during this age, and other lifestyle-related confounds will be lower in this age group.
Who is the study for?
Adolescents aged 14-18 with Major Depressive Disorder or Persistent Depressive Disorder, or those showing significant depressive symptoms. Participants must have a BMI within the 15th to 85th percentile and cannot have liver or kidney disease, allergies to insulin, MRI contraindications, positive pregnancy test, glucose tolerance issues, psychotic illness history, severe substance use disorder (except certain cases for cannabis and alcohol), nor be on specific medications affecting weight or blood pressure.
What is being tested?
The trial is testing whether brain insulin resistance is associated with depression in adolescents. It involves using MRI scans sensitive to brain insulin action. The interventions include Humalog (a rapid-acting insulin) and saline nasal spray as a control comparison.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of Humalog may include low blood sugar levels (hypoglycemia), allergic reactions at the injection site such as redness or swelling, itching and rash. Saline nasal spray is generally safe but can sometimes cause mild irritation or discomfort in the nose.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ peripheral insulin resistance: study visit 1, pre-mri #1 and post-mri #2, and 6-month follow-up study visit; brain insulin resistance: study visit 1, during mri scan #1 and #2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~peripheral insulin resistance: study visit 1, pre-mri #1 and post-mri #2, and 6-month follow-up study visit; brain insulin resistance: study visit 1, during mri scan #1 and #2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The change in brain imaging outcomes, measuring brain insulin resistance, following intranasal insulin or placebo challenges, compared between the participants with depression and healthy controls.
Secondary study objectives
Correlation between brain insulin resistance with cognitive functioning at baseline and 6-month study follow up
Correlation between brain insulin resistance with illness severity and cognitive functioning at baseline and 6-month study follow up
Other study objectives
Correlation between brain insulin resistance and peripheral insulin resistance at baseline and 6-month study follow up
Correlation between brain insulin resistance, and hepatic and visceral adiposity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Crossover: Insulin and PlaceboExperimental Treatment2 Interventions
Twelve adolescents who have a confirmed depression diagnosis or experiencing depression will be used as the study population group against 12 healthy adolescents who will be used as the healthy study population group.
Both the health control group and medication-free adolescents with depression will receive the same drug conditions (intranasal insulin and intranasal placebo).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline nasal spray
2021
Completed Phase 4
~110
Humalog
2007
Completed Phase 3
~1240
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
372 Previous Clinical Trials
82,567 Total Patients Enrolled
90 Trials studying Depression
17,381 Patients Enrolled for Depression
Mahavir Agarwal, MD, PhDPrincipal InvestigatorCentre for Addiction and Mental Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have pre-diabetes or diabetes.I am between 14 and 18 years old.I am taking medication to manage my weight, cholesterol, or blood pressure.I have been diagnosed with Major Depressive Disorder or Persistent Depressive Disorder.I am currently taking antipsychotics or mood stabilizers.I have a history of kidney disease.I have a history of liver disease or my liver enzyme levels are high.I have been diagnosed with MDD or PDD, or scored high for depression on a questionnaire.Your body mass index (BMI) is within the 15th to 85th percentile for your age and gender.
Research Study Groups:
This trial has the following groups:- Group 1: Crossover: Insulin and Placebo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.