Dopamine and Insulin in Psychosis (NCT07252752) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Dopamine and Insulin in Psychosis
Austria46 participantsStarted 2026-01-01
Plain-language summary
Patients with schizophrenia have a high risk of developing metabolic disorders and current evidence points to an overlap in mechanisms underlying psychiatric symptoms and metabolic disturbances. The main goal of this study is to investigate effects of brain insulin on dopamine signaling and energy metabolism in patients with schizophrenia experiencing their first psychotic episode (FEP). To this end, patients with schizophrenia and healthy volunteers will undergo two \[11C\]-(+)-PHNO positron emission (PET) scans to measure the changes in dopamine receptor availability after nasally applied insulin, as well as single proton magnetic resonance spectroscopy (1H-MRS) to assess the impact of intranasal insulin on levels of glucose and glutamate in the hippocampus.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All participants
* age 18-40
* Body mass index (BMI) range 18-25
* good general health according to physical examination and medical history
* absence of relevant abnormalities in laboratory screening, electrocardiogram (ECG) or vital signs
* no regular use of drugs of abuse or alcohol based on history and urine drug screen
Patients only
* diagnosis of schizophrenia or schizophreniform disorder according to DSM-5
* ability to give informed consent
* minimum Positive and Negative Syndrome Scale (PANSS) score of 55 with \>3 on at least two or \>4 on one PANSS psychosis item
Exclusion Criteria:
All participants
* severe or unstable medical or neurological illness or clinically significant abnormality on screening laboratory studies or ECG
* established diagnosis of type 1 or type 2 diabetes
* current substance use disorder or regular recreational drug abuse (except nicotine and caffeine)
* pregnancy or breastfeeding
* history of head trauma resulting in loss of consciousness of \>1min or requiring medical attention
* presence of MRI exclusion criteria
* if participation in this study would exceed annual radiation dose limits (30mSv)
* clinically established diagnosis of intellectual disability
Healthy volunteers only
* Psychiatric disorder according to Mini-International Neuropsychiatric Interview (M.I.N.I.)
* Schizophrenia or bipolar disorder in first degree family members
Patients only
● Previous oral antipsychotic treatment for more than 2 weeks…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
[11C]-(+)-PHNO BPND values
Timeframe: Assessed on two separate study visits within 5-12 days (scan duration: 90 min)
2
Hippocampal glucose and glutamate concentrations
Timeframe: Assessed during a single study visit (scan duration: 40 min in total)