[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612374":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":50,"locations":60,"responsibleParty":74,"collaborators":32,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":32,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":99,"overallStatus":105,"whyStopped":32,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Schizophrenia group","EXPERIMENTAL","20 antipsychotic-naive patients with first episode psychosis will undergo (i) two \\[11C\\]-(+)-PHNO PET scans preceded by intranasal insulin or placebo administration in a randomized counterbalanced order, and (ii) 1H-MRS before and after intranasal insulin",[13,14,15,16,17],"Drug: Intranasal Insulin","Drug: Placebo","Drug: Low dose insulin infusion","Drug: Placebo infusion","Radiation: [11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)",{"label":19,"type":10,"description":20,"interventionNames":21},"Healthy volunteer group","20 healthy volunteers will undergo (i) two \\[11C\\]-(+)-PHNO PET scans preceded by intranasal insulin or placebo administration in a randomized counterbalanced order, and (ii) 1H-MRS before and after intranasal insulin",[13,14,15,16,17],{"label":23,"type":6,"description":24,"interventionNames":25},"Test-retest group","6 healthy volunteers will undergo (i) two \\[11C\\]-(+)-PHNO PET scans, and (ii) 1H-MRS for test-retest purposes",[17],[27,33,37,41,45],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Intranasal Insulin","160 IU intranasal insulin is administered using precision air pumps twice: 15 min prior to the PET scan and 35 min prior to the 1H-MRS scan",[19,9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Placebo","Insulin-free dilution buffer is administered using precision air pumps 15 min prior to the PET scan",[19,9],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Low dose insulin infusion","2.5 mU\u002Fkg insulin in 100 ml isotonic saline is infused intravenously over 15min prior to PET scan when placebo is administered intranasally",[19,9],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Placebo infusion","100 ml saline is infused intravenously over 15min prior to PET scan when insulin is administered intranasally",[19,9],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":32},"RADIATION","[11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)","Each participant undergoes a 90-min \\[11C\\]-(+)-PHNO scan twice",[19,9,23],[51,57],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Matthaeus Willeit","CONTACT","+43 1 40400","35470","matthaeus.willeit@meduniwien.ac.at",{"name":58,"role":53,"phone":54,"phoneExt":55,"email":59},"Irena Dajic","irena.dajic@meduniwien.ac.at",[61],{"facility":5,"status":32,"city":62,"state":32,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Vienna","1090","Austria","AT",{"type":67,"coordinates":68},"Point",[69,70],16.37208,48.20849,{"lat":70,"lon":69},[73],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},{"type":75,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Matthäus Willeit","Ao. Univ. Prof. Dr.","100612374","dopamine-and-insulin-in-psychosis-100612374",false,"NCT07252752","Dopamine and Insulin in Psychosis","Dopamine and Insulin in Psychosis: Imaging the Effects of Intranasal Insulin on Dopamine Transmission","DIPS","Inclusion Criteria:\n\nAll participants\n\n* age 18-40\n* Body mass index (BMI) range 18-25\n* good general health according to physical examination and medical history\n* absence of relevant abnormalities in laboratory screening, electrocardiogram (ECG) or vital signs\n* no regular use of drugs of abuse or alcohol based on history and urine drug screen\n\nPatients only\n\n* diagnosis of schizophrenia or schizophreniform disorder according to DSM-5\n* ability to give informed consent\n* minimum Positive and Negative Syndrome Scale (PANSS) score of 55 with \\>3 on at least two or \\>4 on one PANSS psychosis item\n\nExclusion Criteria:\n\nAll participants\n\n* severe or unstable medical or neurological illness or clinically significant abnormality on screening laboratory studies or ECG\n* established diagnosis of type 1 or type 2 diabetes\n* current substance use disorder or regular recreational drug abuse (except nicotine and caffeine)\n* pregnancy or breastfeeding\n* history of head trauma resulting in loss of consciousness of \\>1min or requiring medical attention\n* presence of MRI exclusion criteria\n* if participation in this study would exceed annual radiation dose limits (30mSv)\n* clinically established diagnosis of intellectual disability\n\nHealthy volunteers only\n\n* Psychiatric disorder according to Mini-International Neuropsychiatric Interview (M.I.N.I.)\n* Schizophrenia or bipolar disorder in first degree family members\n\nPatients only\n\n● Previous oral antipsychotic treatment for more than 2 weeks or previous treatment with antipsychotic depot preparation",true,"ALL","18 Years","40 Years",{"count":91,"type":92},46,"ESTIMATED","INTERVENTIONAL",[95],"NA","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.",[98],"First Episode Psychosis (FEP)",[100,101,102,103,104],"positron emission tomography (PET)","dopamine","schizophrenia","intranasal insulin","magnetic resonance spectroscopy (MRS)","NOT_YET_RECRUITING","2025-11-18",{"date":108,"type":109},"2025-11-28","ACTUAL",{"date":111,"type":92},"2026-01-01",{"date":113,"type":92},"2029-01-01",{"name":5,"class":6},1]