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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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