NCT07252752Not yet recruiting
Dopamine and Insulin in Psychosis
Dopamine and Insulin in Psychosis: Imaging the Effects of Intranasal Insulin on Dopamine Transmission
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- First submitted
- 30 Sept 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Jan 2029
- Lead sponsor
- Medical University of Vienna
- Diseases
- Schizophrenia
- NCT number
- NCT07252752
What you commit to
- Study type: Interventional
- Planned participants: 46
- From 1 Jan 2026 to the primary completion date, 1 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- if participation in this study would exceed annual radiation dose limits (30mSv)
- Schizophrenia or bipolar disorder in first degree family members
- Patients only
- ● Previous oral antipsychotic treatment for more than 2 weeks or previous treatment with antipsychotic depot preparation
Other illness
- established diagnosis of type 1 or type 2 diabetes
- current substance use disorder or regular recreational drug abuse (except nicotine and caffeine)
- history of head trauma resulting in loss of consciousness of \>1min or requiring medical attention
- Psychiatric disorder according to Mini-International Neuropsychiatric Interview (M.I.N.I.)
Lab values
- severe or unstable medical or neurological illness or clinically significant abnormality on screening laboratory studies or ECG
Other
- All participants
- pregnancy or breastfeeding
- presence of MRI exclusion criteria
- clinically established diagnosis of intellectual disability
- Healthy volunteers only
Who the study is looking for
- 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
Age in the registry: 18 years to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.