- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03597893
Effects of Intranasal Oxytocin and Stress on Belief Updating
Effects of Intranasal Oxytocin and Induced Stress on People's Belief Updating
Обзор исследования
Подробное описание
In a randomized, double-blind, placebo controlled between-subjects design, healthy male volunteers receive intranasal oxytocin or placebo under stress or non-stress group prior belief updating task.
The Trier Social Stress Test (TSST) was used to induce psychosocial stress - this standardized technique enables a naturalistic exposure to a psychosocially stressful situation. This method consists primarily of a public speaking in second language (English) and a mental arithmetic task performed in front of a panel. Participants were not informed of the tasks prior to their recruitment. At the start of the TSST, they were told to prepare a 5-min speech to an unknown panel on personal suitability for their ideal job; the job description was matched to each participant, taking into consideration his personal aspirations. After the instructions, subjects were given 10 minutes of solitary preparation for this task. Then, they entered the TSST room and were told to start the presentation in front of a panel of two formally-dressed judges (one male and one female) and a conspicuous video camera. Any pause during the speech prompted a reminder from the judges of the remaining time. The interview was followed by 5 minutes of mental arithmetic performed out loud. Subjects were instructed to serially subtract 13 from 1022 as quickly and accurately as possible in front of the panel. If a mistake was made, the subject was told to start over from the beginning. After the mental arithmetic task, the TSST was concluded - subjects were confronted with the psychosocially stressful situation for a total of 10 minutes.
Non-stress groups first underwent a 5-minute session of travel magazine reading with two casually-dressed people (one male and one female), then did as many easy arithmetic questions within 5 minutes on paper. Participants were told that none of their answers would be marked.
All participants completed two sessions of self life event estimations, each with the same set of 40 adverse life events. The subjects were first presented with the events, then were instructed to estimate their likelihood (0-99%) of experiencing each event in the future (first Estimate, E1) and rate their confidence in their estimate. They were then presented with the actual probability of each event occurring to an average person in a similar environment (Feedback, F) and asked to rate their acceptance of the presented feedback. Five minutes after the first session, participants were instructed to perform the same task and provide their second estimate (E2) for the same 40 events in a randomized order and were, again, instructed to rate their confidence in their estimate. This time, however, no feedback was given. This process was repeated for a friend life event estimation session. After the second session, participants were given a surprise memory test for the presented feedback.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- healthy subjects without past or current psychiatric or neurological disorders
Exclusion Criteria:
- subjects with past or current psychiatric or neurological disorders
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: Oxytocin
Oxytocin (OXT), a neuropeptide produced in the hypothalamus, is a key modulator of complex socioaffective responses including affiliation, social approach and attachment, stress and anxiety.
Subjects receiving an intranasal spray of OXT (24 IU or 40.32 mg; Syntocinon-spray; Novartis, Switzerland) .
|
интраназально
|
Плацебо Компаратор: Placebo
Placebo contains all ingredients except for the peptide in three puffs of 3.99 IU per 6.72mg nostril.
|
intranasally administrated
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
The updated probability estimation for negative events in the four experimental groups
Временное ограничение: 40~125 minutes after drug administration
|
Using the second estimation value to minus the first estimation value to get the update value, as well as calculating the update value in desirable condition (first estimation < feedback) and undesirable condition (first estimation < feedback).
Then investigated the general belief updating (gBU) and optimistic belief updating (using desirableBU-undesirableBU) in the four experimental condition (i.e., oxytocin-stress, oxytocin-nonstress, placebo-stress, placebo-nonstress).
|
40~125 minutes after drug administration
|
The salivary cortisol level in four experimental groups
Временное ограничение: 40~125 minutes after drug administration
|
Conducted ANOVA to test salivary cortisol level in the four experimental groups
|
40~125 minutes after drug administration
|
The correlation between personality traits and belief updating value in four experimental groups
Временное ограничение: 40~125 minutes after drug administration
|
Conducted correlation analysis to explore which personality traits would modulate the oxytocin effect or stress effect.
|
40~125 minutes after drug administration
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- OB-OT and stress
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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