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临床试验/NCT07093060
NCT07093060招募中1 期

The Influence and Regulatory Role of Exogenous and Endogenous Oxytocin on Social Attention in Humans

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年6月9日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
250
试验地点
1
主要终点
Fixation duration

研究概览

简要总结

The main aim of the present study is to investigate whether orally (lingual spray) administered oxytocin influences human social attention and behaviors via oxytocin receptors and whether its effects are dose- and task-dependent.

详细描述

In a placebo-controlled double-blind between-subject design experiment, investigators plan to investigate whether oral (lingual spray) oxytocin influences human social attention and behaviors via the oxytocin receptor and whether its effects are dose- and task-dependent. Participants complete questionnaires in Chinese versions before treatment administration, including Trait Anxiety Inventory, State Anxiety Inventory, Liebowitz Social Anxiety Scale, Beck Depression Inventory, Autism Spectrum Quotient. Then the first blood (6 ml via indwelling medial cubital vein catheter) and saliva (1-2 ml, passive drool) samples are collected, followed by the first self-administered medication (three sublingual and three supragingival administrations, alternating separated by 30 seconds). After a 15-minute interval, the second medication is administered, with a second blood sample collected immediately afterwards. Participants then remain in the lab for 30 minutes (mobile phone use and conversation with experimenters prohibited during this period). Behavioral experiments commence after the third blood collection. Behavioral experiment consists of four visual attention paradigms including a dynamic task simultaneously contrasting social stimuli (individuals dancing) with geometric patterns; social directed attention using a gaze following paradigm; face emotion processing, and empathy for individuals depicted in natural scenes exhibiting strong positive or negative emotions. During these phases, participants' fixation time, fixation counts and pupil size on specified areas of interest during each visual attention paradigm will be measured using eye tracking equipment. Immediately after completion of the paradigm, participants will complete the state anxiety questionnaire again to assess treatment/paradigm effects on anxiety.

MANOVA tests followed by appropriate post-hoc analyses will be performed on eye-tracking and other data to assess treatment effects. Correlation analysis will be used to assess associations between trait autism scores and outcome measures in the different groups.

Investigators hypothesize that oral oxytocin treatment will dose-dependently facilitate enhanced interest in social stimuli or features in the different visual attention paradigms and dose-dependently increase oxytocin concentrations. Investigators additionally hypothesize that the oxytocin receptor antagonist, atosiban, will reduce interest in social stimuli or features and will prevent facilitatory effects of oxytocin administration but not influence oxytocin concentrations. Investigators hypothesize that oxytocin treatment will increase pupil diameter while viewing some of the social stimuli. Investigators hypothesize that there will be no treatment-dependent effects on state anxiety. Investigators hypothesize that oxytocin effects on enhancing social attention will be greater in individuals with higher scores on trait autism.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy male subjects without past or current psychiatric or neurological disorders

排除标准

  • History of or current neurological/psychiatric disorders;
  • Use of psychotropic medications (including nicotine)
  • Visual impairments

研究组 & 干预措施

Atosiban and 24IU oxytocin group

Experimental

Interventions are atosiban 150ug followed after 15 minutes by the lower (24IU) dose of oxytocin

干预措施: Atosiban (Drug)

oxytocin 24IU group

Experimental

Interventions are placebo followed after 15 min by the lower dose (24IU) oxytocin

干预措施: Oxytocin lower dose (24IU) (Drug)

oxytocin 24IU group

Experimental

Interventions are placebo followed after 15 min by the lower dose (24IU) oxytocin

干预措施: Placebo (Drug)

atosiban group

Experimental

Interventions are placebo followed after 15 minutes by 150ug atosiban

干预措施: Atosiban (Drug)

atosiban group

Experimental

Interventions are placebo followed after 15 minutes by 150ug atosiban

干预措施: Placebo (Drug)

placebo group

Placebo Comparator

Interventions are placebo followed after 15 minutes by another placebo

干预措施: Placebo (Drug)

oxytocin 48IU group

Experimental

Interventions are placebo followed after 15 minutes by the higher 48IU oxytocin dose

干预措施: Oxytocin higher dose (48IU) (Drug)

oxytocin 48IU group

Experimental

Interventions are placebo followed after 15 minutes by the higher 48IU oxytocin dose

干预措施: Placebo (Drug)

Atosiban and 24IU oxytocin group

Experimental

Interventions are atosiban 150ug followed after 15 minutes by the lower (24IU) dose of oxytocin

干预措施: Oxytocin lower dose (24IU) (Drug)

结局指标

主要结局

Fixation duration

时间窗: Fixation durations will be taken for each of the areas of interest in the four different visual paradigms starting 45 minutes post-treatment from the beginning of each paradigm until the end of each paradigm (each paradigm lasts around 10 minutes)

Fixation time on different areas of interest in the different visual presentation paradigms using eye-tracking

Fixation counts

时间窗: Fixation counts will be taken for each of the areas of interest in the four different visual paradigms starting 45 minutes post-treatment, from the beginning of each paradigm until the end of each paradigm (each paradigm lasts around 10 minutes).

Total number of fixations made by participant towards the different areas of interest in the different visual paradigms using eye-tracking

次要结局

  • Oxytocin concentration(Blood samples taken at time 0 (baseline), 15 minutes after first treatment, and 30 minutes after second treatment. Saliva samples taken at time 0 (baseline) and after visual paradigms (around 90 minutes post treatment).)
  • Pupil size(Pupil size will be measured starting 45 min post-treatment during the whole of each of the different visual presentation paradigms (around 10 minutes for each paradigm).)
  • State anxiety(Subjects will complete the questionnaire twice, once immediately prior to treatment (baseline) and a second time immediately after completion of the four visual paradigms (around 90 minutes post treatment).)

研究者

发起方
University of Electronic Science and Technology of China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Keith Kendrick

Professor

University of Electronic Science and Technology of China

研究点 (1)

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