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临床试验/NCT03597893
NCT03597893已完成不适用

Effects of Intranasal Oxytocin and Induced Stress on People's Belief Updating

Beijing Normal University0 个研究点目标入组 131 人开始时间: 2016年12月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
131
主要终点
The updated probability estimation for negative events in the four experimental groups

研究概览

简要总结

To investigate the effect of 24IU intranasal oxytocin on belief updating when people in stress or non-stress condition.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • healthy subjects without past or current psychiatric or neurological disorders

排除标准

  • subjects with past or current psychiatric or neurological disorders

研究组 & 干预措施

Oxytocin

Experimental

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) .

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

Placebo contains all ingredients except for the peptide in three puffs of 3.99 IU per 6.72mg nostril.

干预措施: Placebo (Drug)

结局指标

主要结局

The updated probability estimation for negative events in the four experimental groups

时间窗: 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).

The salivary cortisol level in four experimental groups

时间窗: 40~125 minutes after drug administration

Conducted ANOVA to test salivary cortisol level in the four experimental groups

The correlation between personality traits and belief updating value in four experimental groups

时间窗: 40~125 minutes after drug administration

Conducted correlation analysis to explore which personality traits would modulate the oxytocin effect or stress effect.

次要结局

未报告次要终点

研究者

发起方
Beijing Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ma, yina

Principal Investigator

Beijing Normal University

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