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Hormone Therapy

Intranasal Insulin for Schizophrenia

N/A
Recruiting
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
17-45 years of age
17-45 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up scan duration is ~90 minutes
Awards & highlights

Summary

This trial will study the relationship between metabolic health and cognitive function in individuals with schizophrenia. Cognitive impairment is a common challenge for those with schizophrenia and can contribute to disability and poor outcomes. Many patients with schizophrenia

Who is the study for?
This trial is for right-handed individuals aged 17-45, who have been diagnosed with schizophrenia or related conditions and are either new to antipsychotic treatment or have had limited exposure. They should not be obese (BMI ≤27). The study also includes healthy subjects without these disorders.
What is being tested?
The study tests the effects of intranasal insulin on brain function in people with schizophrenia compared to healthy controls. It measures how the brain uses glucose after an insulin stimulus using a PET scan, aiming to understand cognitive and metabolic dysfunction in schizophrenia.
What are the potential side effects?
While specific side effects are not listed here, intranasal insulin could potentially cause nasal irritation, headache, or hypoglycemia. Placebo treatments typically do not cause side effects but may include similar symptoms due to psychological factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 17 and 45 years old.
Select...
I am between 17 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~scan duration is ~90 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and scan duration is ~90 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
[18F]-FDG brain uptake

Trial Design

2Treatment groups
Experimental Treatment
Group I: Schizophrenia GroupExperimental Treatment2 Interventions
Insulin (160IU) or placebo is administered intranasally 15 minutes prior to the PET scan.
Group II: Healthy Control GroupExperimental Treatment2 Interventions
Insulin (160 IU) or placebo is administered intranasally 15 minutes prior to the PET scan.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intranasal insulin
2006
Completed Phase 2
~190
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor
366 Previous Clinical Trials
82,316 Total Patients Enrolled
58 Trials studying Schizophrenia
4,211 Patients Enrolled for Schizophrenia
~5 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
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