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临床试验/NCT04443647
NCT04443647已完成不适用

Influence of Oxytocin on Approach-avoidance Tendencies to Social and Non-social Stimuli

KU Leuven1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年12月15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
KU Leuven
入组人数
64
试验地点
1
主要终点
Change in EEG frontal alpha asymmetry after nasal spray administration

研究概览

简要总结

In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry). Also assessments of autonomic arousal, based on skin conductance recordings will be collected.

详细描述

The neuropeptide oxytocin (OT) plays an important role in a wide-range of complex social behaviors. Recently however, the 'social' specificity of OT's action has been challenged, considering several observations of non-social effects of OT showing for example that OT reliably reduces stress also in non-social tasks.

To account for these non-social effects of OT, the General Approach-Avoidance Hypothesis of OT (GAAO) has been put forward, positing that OT primarily modulates approach/ avoidance motivational tendencies and behaviors by impacting on the mesocorticolimbic circuitry linked to reward (approach) as well as cortico-amygdala circuits linked to threat (avoidance) (Harari-Dahan and Bernstein, 2014). Since the neural substrates underlying 'social' approach and avoidance are not distinct from those underlying 'non-social' approach and avoidance, the GAAO posits that the modulatory effects of OT should not be limited to social behaviors. In this view, the GAAO puts forward that OT may indeed enhance the attentional salience of many social cues, but not because they are social per se; but because many social stimuli are emotionally-evocative and personally-relevant.

In this study, a randomized, placebo-controlled between-subject design is adopted to investigate the effect of a single-dose of intranasally administered OT on approach-avoidance related motivational tendencies during the processing of a series of social and non-social, positively and negatively valenced stimuli. To obtain a behavioral measure of approach-avoidance tendencies, participants will be able to control the viewing time of the presented stimuli, by pressing 'up' or 'down' on a keyboard. During stimulus presentation neurophysiological recordings will be performed to obtain a neural measure of approach-avoidance motivational tendencies, based on electroencephalographic recordings (EEG: frontal alpha asymmetry). Also electrodermal recordings (skin conductance) will be collected to obtain assessments of sympathetically-driven autonomic arousal.

In accordance to the GAAO account, it is hypothesized that OT will reduce avoidance-related motivational tendencies (assessed behaviorally and using EEG), irrespective of sociality (i.e. similar effect towards social and non-social stimuli).

In accordance to prior research, skin conductance responses are hypothesized to reduce after OT, indicating reduced sympathetically-driven autonomic arousal. On the other hand, considering the implicated role of sympathetic arousal in orienting responses, OT might also facilitate an enhancement of skin conductance responses, i.e., being reflective of OT's role in enhancing salience toward emotionally-evocative stimuli.

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
Triple (Participant, Investigator, Outcomes Assessor)

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

  • right-handed
  • age between 18 and 35
  • Normal or adjusted-to-normal vision (with lenses only)
  • Dutch as mother tongue

排除标准

  • age below 18 or above 35
  • neurological or psychiatric condition (e.g. epilepsy, stroke, concussion), (e.g. anxiety disorder, depression)
  • use of psychotropic medication (e.g. anxiolytics, antidepressants)

研究组 & 干预措施

Oxytocin

Experimental

Syntocinon nasal spray (40 IU/ml; oxytocin, product code RVG 03716); single intranasal dose of 24 international units (IU; 3 puffs of 4 IU per nostril)

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

Saline natriumchloride solution nasal spray; single intranasal dose (3 puffs per nostril)

干预措施: Placebo (Drug)

结局指标

主要结局

Change in EEG frontal alpha asymmetry after nasal spray administration

时间窗: Average over trials, baseline and approximately 30 minutes after nasal spray administration

The influence of oxytocin administration on EEG frontal alpha asymmetry

Change in behavioral approach-avoidance (number of up or down key presses, prolonging or shortening the viewing time towards presented stimuli)

时间窗: Average over trials, baseline and approximately 30 minutes after nasal spray administration

During the presentation of a series of stimuli, participants will be able to prolong or shorten the viewing time towards the presented stimuli, by pressing an 'up' or 'down' key on a keyboard. The number of up versus down key-presses will be taken as a measure of behavioral approach-avoidance. The influence of oxytocin administration on the number of up or down key presses will be assessed.

Change in skin conductance (type of electrodermal recording) after nasal spray administration

时间窗: Average over trials, baseline and approximately 30 minutes after nasal spray administration

The influence of oxytocin adminstration on skin conductance

次要结局

未报告次要终点

研究者

发起方
KU Leuven
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kaat Alaerts

Prof. dr.

KU Leuven

研究点 (1)

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