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New treatment option for Schizophrenia
Official title Does Abnormal Insulin Action in the Brain Underlie Cognitive and Metabolic Dysfunction in Schizophrenia
ClinicalTrials.gov ID: NCT05748990
What this study is testing
What is Intranasal insulin?
Intranasal insulin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for schizophrenia.
Also referred to as Humalog.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Cognitive impairment (such as challenges in thinking and memory) is a core aspect of schizophrenia (SCZ), contributing to disability and poor functional outcomes. Additionally, almost half of the patients with SCZ are obese, the prevalence of type 2 diabetes is 3-6 times higher, and life expectancy is lower by 15-20 years compared to the general population.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 17 to 45. Healthy volunteers may be eligible.
You may be able to join if
- i) Experimental group (participants with a diagnosis of schizophrenia spectrum disorder):
- 17-45 years
- both sexes;
- Patients with first-episode schizophrenia spectrum illness: Primary DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform...
- BMI under or equal to 27 ii) Control group (healthy controls):
You likely can't join if
- moderate or severe substance use according to MINI (per PI discretion in the case of moderate alcohol or cannabis use)
- prediabetes, diabetes, or evidence of impaired glucose tolerance on screening OGTT
- acute suicidal risk
- use of weight, lipid, antidiabetic or blood pressure reducing agents
- liver or kidney disease
- pregnancy
See the full eligibility criteria
- i) Experimental group (participants with a diagnosis of schizophrenia spectrum disorder):
- 17-45 years
- both sexes;
- Patients with first-episode schizophrenia spectrum illness: Primary DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, brief psychotic disorder, psychotic...
- BMI under or equal to 27 ii) Control group (healthy controls):
- 17-45 years of age
- sex-,
- hand dominance -and
- body mass index (BMI)-matched
- Absence of DSM-5 diagnosis other than a specific phobia according to MINI
- moderate or severe substance use according to MINI (per PI discretion in the case of moderate alcohol or cannabis use)
- prediabetes, diabetes, or evidence of impaired glucose tolerance on screening OGTT
- acute suicidal risk
- use of weight, lipid, antidiabetic or blood pressure reducing agents
- liver or kidney disease
- pregnancy
- nursing
- pacemakers
- metallic cardiac valves
- magnetic material such as surgical clips, implanted electronic infusion pumps or any other conditions that would preclude the MRI scan
- clinically significant claustrophobia (determined from MRI screening form; significance evaluated as per QI's discretion).
- history of head trauma resulting in loss of consciousness \> 30 minutes that required medical attention;
- size of head, neck, precluding to fit in the MRI or PET scanners
- weight over 350lbs (limit for MRI scanner bed)
- unstable physical illness
- significant neurological disorder including a seizure disorder;
- Received maximum allowed radiation in the past 12 months (20 mSv)
- Completed more than 6 PET scans/ lifetime, that, together with the PET scanning procedures under this protocol will bring the total number of PET scans to more than the allowed/lifetime (8 PET scans per lifetime). These...
- clinically relevant abnormality observed in medical history,
- current intake of any medication that may interfere with participation in the study or may confound the results of PET imaging (e.g. anti-diabetic medication).
- Disorders of coagulation, blood or ongoing use of anticoagulant medication Control group: Exclusionary criteria are as listed above for participants, in addition to: 1) First degree family member with primary psychotic...
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 17 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.