← Back to Search

Hormone Therapy

Schizophrenia Group 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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ scan duration is ~90 minutes

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

[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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

356 Previous Clinical Trials

81,438 Total Patients Enrolled

58 Trials studying Schizophrenia

4,211 Patients Enrolled for Schizophrenia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current total number of participants being recruited for this clinical study?

"Indeed, the details on clinicaltrials.gov indicate that this study is actively seeking participants. The trial was first posted on April 1st, 2023 and underwent its latest revision on January 11th, 2024. A total of 20 individuals will be enrolled in this clinical trial at a single site."

Answered by AI

Is the age criterion for participation in this study limited to individuals below 25 years old?

"Individuals between the ages of 17 and 45 are eligible for enrollment in this trial."

Answered by AI

Which individuals are eligible to participate in this research study?

"This clinical trial aims to enroll 20 individuals, aged between 17 and 45 years, who have been diagnosed with schizophrenia. Noteworthy inclusion criteria include right-handedness and being either antipsychotic naïve or having received antipsychotic treatment for three weeks or less within the past three months (medication confirmation through CAMH chart review). Participants are not required to discontinue antipsychotics during the study. Additionally, patients with a first-episode of schizophrenia spectrum illness may also be included if they meet specific DSM-5 diagnostic criteria as confirmed by CAMH chart review. Other important eligibility factors include a BMI equal to"

Answered by AI

Are there ongoing efforts to actively enroll participants for this medical study?

"According to the current information on clinicaltrials.gov, this study is actively seeking participants. The trial was initially published on April 1st, 2023 and underwent recent revisions as of January 11th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia

2023. "Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05748990.

All > Insulin