Набор скоро начнётся NCT07252752

Dopamine and Insulin in Psychosis

Без фазы С лечением First Episode Psychosis (FEP)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Intranasal Insulin, Placebo, Low dose insulin infusion, Placebo infusion.
Кому может быть актуально: Состояния в реестре: First Episode Psychosis (FEP). Базовые параметры: 18 лет — 40 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Австрия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Dopamine and Insulin in Psychosis: Imaging the Effects of Intranasal Insulin on Dopamine Transmission

Обзор

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.

Вмешательства

Препарат 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
Препарат Placebo
Insulin-free dilution buffer is administered using precision air pumps 15 min prior to the PET scan
Препарат Low dose insulin infusion
2.5 mU/kg insulin in 100 ml isotonic saline is infused intravenously over 15min prior to PET scan when placebo is administered intranasally
Препарат Placebo infusion
100 ml saline is infused intravenously over 15min prior to PET scan when insulin is administered intranasally
Лучевая терапия [11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)
Each participant undergoes a 90-min \[11C\]-(+)-PHNO scan twice

Первичные конечные точки

[11C]-(+)-PHNO BPND values [Срок оценки: Assessed on two separate study visits within 5-12 days (scan duration: 90 min)]
Hippocampal glucose and glutamate concentrations [Срок оценки: Assessed during a single study visit (scan duration: 40 min in total)]

Вторичные конечные точки (2)

Changes in blood-based parameters of energy metabolism [Срок оценки: Assessed at baseline and at 15min intervals after instranasal insulin/placebo administration over a period of up to 90min]
Hippocampal volumetric parameters [Срок оценки: Assessed during a single study visit, at baseline (scan duration: 10min)]

Критерии участия

Критерии включения

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

Критерии исключения

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 or previous treatment with antipsychotic depot preparation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да