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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 outcome measures
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
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
2022
Completed Phase 3
~1270
Find a Location
Who is running the clinical trial?
Centre for Addiction and Mental HealthLead Sponsor
356 Previous Clinical Trials
81,434 Total Patients Enrolled
85 Trials studying Depression
19,227 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is the patient population involved in this medical experiment?
"Affirmative. The evidence on clinicaltrials.gov attests that this scientific research, which was posted in September 2021 and last modified in October 2022, is presently enrolling participants. 24 test subjects need to be enrolled from a single site."
Answered by AI
Are individuals more than 25 years of age eligible to participate in this trial?
"This particular clinical trial calls for participants aged between 14 and 18, a subset of people that have 215 other medical studies exclusively catering to them. For comparison, those 65 years old or above are eligible in 1057 different trials."
Answered by AI
Are investigators currently seeking new participants for this experiment?
"Affirmative. Clinicaltrials.gov data indicates that this trial, first posted on September 1st 2021 is actively recruiting participants to join the study. 24 patients are needed from one medical centre for proper enrolment in the research project."
Answered by AI
Does this research initiative include opportunities for me to participate?
"Enrolment in this trial is restricted to 24 youths between the ages of 14 and 18 who are diagnosed with major depressive disorder (MDD). The body mass index must be within normal parameters, they must be right handed, not currently taking any psychotropic medications or have been off them for at least 3 months."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
What site did they apply to?
Centre for Addiction and Mental Health
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