跳至主要内容
临床试验/NCT04134663
NCT04134663已完成不适用

Comparison of Direct and Indirect Effects of Intranasal Oxytocin Using Co-administration With a Vasoconstrictor

University of Electronic Science and Technology of China1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2019年3月2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
96
试验地点
1
主要终点
blood oxytocin concentration

研究概览

简要总结

This study aims to dissociate direct from indirectly mediated effects of intranasal oxytocin administration by using treatment with or without prior intranasal administration of a vasoconstrictor to reduce peripheral increases in peptide concentrations. Primary outcomes of the randomized placebo-controlled double-blind experiment are blood oxytocin concentration and oxytocin-associated responses in central and peripheral systems.

Intranasal application of the neuropeptide oxytocin has been reported to produce a number of neural, physiological and behavior effects which may be of potential therapeutic relevance, but it is unclear the extent to which they are mediated directly via the peptide entering the brain or indirectly as a result of increased peripheral concentrations. In the current placebo-controlled, double blind experiment on healthy adult male subjects the investigators will measure the effects of a single dose of intranasal oxytocin (24IU) on brain activity (using electroencephaolography - EEG) as well as on cardiac (heart-rate and heart-rate variablility) and gastric (electrogastrogram - EGG) activity and physiological arousal (skin conductance response - SCR). The pattern of functional effects observed will be compared with subjects receiving intranasal pretreatment with a vasoconstrictor prior to oxytocin in order to reduce the amount of oxytocin entering the peripheral circulation. The investigators hypothesize that prior administration of the vasoconstrictor will greatly reduce blood oxytocin concentrations following intranasal oxytocin treatment. Where neural/physiological effects are also affected, this will indicate an indirectly mediated action of intranasally administered oxytocin whereas if they are not this will indicate a directly mediated action.

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 30 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

  • history of head injury
  • medical or psychiatric illness.

研究组 & 干预措施

vasoconstrictor's placebo + intranasal oxytocin group

Active Comparator

subjects receive the vasoconstrictor's placebo followed by oxytocin

干预措施: vasoconstrictor's placebo and oxytocin treatment (Drug)

vasoconstrictor + intranasal oxytocin group

Experimental

subjects receive the vasoconstrictor followed by oxytocin

干预措施: vasoconstrictor and oxytocin treatment (Drug)

vasoconstrictor + intranasal oxytocin placebo group

Placebo Comparator

subjects receive the vasoconstrictor followed by intranasal oxytocin's placebo

干预措施: vasoconstrictor and oxytocin's placebo treatment (Drug)

结局指标

主要结局

blood oxytocin concentration

时间窗: 2 hours

blood oxytocin concentration changes following vasoconstrictor/placebo and oxytocin/placebo treament

resting EEG time-frequency

时间窗: 2 hours

resting EEG time-frequency changes following vasoconstrictor/placebo and oxytocin/placebo treament

次要结局

  • heartrate(2 hours)
  • gastrointestinal activity(2 hours)
  • skin conductance(2 hours)

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