跳至主要内容
临床试验/NCT07140237
NCT07140237招募中1 期

The Influence and Regulatory Role of Exogenous and Endogenous Oxytocin on Top-down 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9月1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
Error rates in prosaccade and antisaccade trials

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 top-down attention 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 top-down attention via the oxytocin receptor and whether its effects are dose- and task-dependent. Subjects complete questionnaires in Chinese versions before treatment administration, including Behavioral Activation System scale, Behavioral Inhibition System scale,Trait Anxiety Inventory, State Anxiety Inventory, Liebowitz Social Anxiety Scale, Beck Depression Inventory, Autism Spectrum Quotient. Then the first blood (6ml 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. Subjects then remain in the lab for 30 minutes (mobile phone use and conversation with experimenters are prohibited during this period). Behavioral experiment (antisaccade) commences after the third blood collection. During these phases, subjects' latency of correct trials, error rate and pupil size in response to stimuli will be measured using eye tracking equipment. Immediately after completion of the paradigm subjects will complete the state anxiety questionnaire again to assess treatment/paradigm effects on anxiety.

A Mixed linear model, followed by appropriate post-hoc analyses will be used on eye-tracking and other data to assess treatment effects. Correlation analysis will be used to assess associations between latency of correct trials in prosaccade and error rate in antisaccade in the different groups. Investigators make the following hypotheses according to our previous studies: first, oral oxytocin treatment will dose-dependently decrease top-down attention to social but also non-social stimuli; secondly, oxytocin concentrations will be dependent on the dose of oral administration and will not be influenced by oral administration of the oxytocin receptor antagonist (atosiban) administration; thirdly, atosiban is anticipated to have the opposite effect of oral oxytocin and may not interfere with top-down attention; fourthly, oxytocin treatment will increase pupil diameter while viewing social stimuli; fifthly, there will be treatment- dependent effects on post-task state anxiety scores; lastly, antisaccade performance in each group might be influenced by subjects' scores on autistic traits.

研究设计

研究类型
Interventional
分配方式
Non 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 group

Experimental

Interventions are placebo followed after 15 minutes by 150ug atosiban

干预措施: Atosiban (Drug)

Oxtocin 24IU group

Experimental

Interventions are placebo followed after 15 minutes by the lower does (24IU) oxytocin

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

Oxtocin 24IU group

Experimental

Interventions are placebo followed after 15 minutes by the lower does (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: 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 does

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

Oxytocin 48IU group

Experimental

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

干预措施: Placebo (Drug)

Atosiban and 24IU oxytocin group

Experimental

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

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

Atosiban and 24IU oxytocin group

Experimental

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

干预措施: Atosiban (Drug)

结局指标

主要结局

Error rates in prosaccade and antisaccade trials

时间窗: Starting 45 minutes post-treatment subjects will complete the eye-tracking task with data on numbers of prosaccade and antisaccade errors being collected continuously over a period of 35 minutes.

Error rates in prosaccade and antisaccade using eye- tracking technique

Responses latencies for prosaccades and antisaccades

时间窗: Starting 45 minutes post-treatment subjects will complete the eye-tracking task with data on prosaccade and antisaccade response times taken continuously during the 35 minute task

response latencies for correct first saccades will be measured on each prosaccade or antisaccade trial using eye-tracking

次要结局

  • Oxytocin concentration(On the day of the experiment blood and saliva samples will be taken at time 0 (baseline) immediately prior to the first treatment, a 2nd sample will be taken at 15 minutes and a 3rd sample at 45 minutes post-treatment.)
  • Pupil size(Starting 45 minutes post-treatment continuous eye-tracking will be used to measure changes in pupil size during the whole of the 35 minute antisaccade task)
  • State anxiety(On the day of the experiment subjects will complete the questionnaire immediately prior to treatment at time 0 (baseline) and again 75 minutes post-treatment after completion of the antisaccade task)
  • Correlation between prosaccade latency and antisaccade errors(Starting 45 minutes post-treatment subjects will complete the eye-tracking task with data being collected continuously over a 35 minute period)

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)

Loading locations...

相似试验