Effects of Oromucosal Oxytocin and Arginine Vasopressin on Top-Down and Bottom-Up Attention to Emotional Faces: A Randomized Placebo-Controlled fMRI Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Behavioral Performance in the Emotional Face Attention Tasks
研究概览
简要总结
The goal of this clinical trial is to learn how 24 IU oxytocin (OT) and 24 IU arginine vasopressin (AVP), administered through the oral mucosa, affect attention to emotional faces and related brain activity in healthy adults. The study will compare OT and AVP with a placebo (PLC).
The main questions it aims to answer are:
- Does oromucosally administered oxytocin produce a behavioral pattern of modulation of top-down and bottom-up attention to emotional faces that is qualitatively consistent with previously reported intranasal oxytocin effects, and how does this pattern compare with that produced by arginine vasopressin?
- Do oromucosally administered oxytocin and arginine vasopressin modulate neural responses within predefined brain regions and networks involved in emotional salience, attentional control, and social information processing, and are these neural effects consistent with their behavioral effects?
- Do oxytocin and arginine vasopressin show overlapping or distinct patterns of neural modulation across top-down and bottom-up attention and high and low attentional load conditions? Researchers will compare 24 IU OT and 24 IU AVP with a placebo to determine how these treatments influence emotional face attention and brain activity.
Participants will:
- Receive 24 IU OT, 24 IU AVP, or placebo via a lyophilized oromucosal lollipop
- Allow the treatment to be absorbed through the oral mucosa for about 5 minutes
- Provide blood samples before and after treatment to assess peripheral oxytocin and vasopressin levels
- Complete emotional face attention tasks during fMRI scanning
- Have response time, response accuracy, brain activity, and peripheral neuropeptide levels measured
- Complete questionnaires assessing mood states and personality traits before treatment administration to control for potential confounding effects
详细描述
Oxytocin (OT) and arginine vasopressin (AVP) are neuropeptides involved in social and emotional processing. Previous studies have shown that intranasal OT can modulate top-down and bottom-up attention to emotional faces. Other work has also suggested that OT and AVP may exert both overlapping and distinct effects on social attention. In addition, emerging evidence indicates that oromucosal and intranasal OT administration may produce similar behavioral effects but different neural response patterns. The present study therefore extends previous work by examining the behavioral and neural effects of oromucosally administered OT and AVP within the same emotional attention paradigm.
In a randomized, placebo-controlled, double-blind, between-subject design, healthy adults will receive 24 IU OT, 24 IU AVP, or placebo (PLC) via a lyophilized oromucosal lollipop. Participants will allow the treatment to be absorbed through the oral mucosa for approximately 5 minutes, followed by a 30-minute resting period and post-treatment blood sampling before fMRI scanning.
To control for potential confounding effects and individual differences, participants will complete the Autism Spectrum Quotient, State-Trait Anxiety Inventory, Beck Depression Inventory, and Toronto Alexithymia Scale before treatment administration. Current affective state will be assessed using the Positive and Negative Affect Schedule (PANAS) at three time points: upon arrival at the laboratory, at the beginning of the scanning task, and after completion of the scan.
During fMRI, participants will complete emotional face attention tasks assessing top-down and bottom-up processing under high and low attentional load. Response time, response accuracy, task-evoked BOLD signals, and peripheral neuropeptide levels will be measured to characterize similarities and differences in the effects of OT and AVP on emotional attention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects without past or current psychiatric or neurological disorders
- •Normal or corrected-to-normal vision
- •Eligible for MRI scanning and willing to undergo blood sampling and study treatment administration
- •For naturally cycling female participants, willingness and ability to complete the experimental session within the predefined menstrual-cycle phase, determined using menstrual history and urinary luteinizing hormone (LH) testing
- •Willing to comply with study requirements regarding alcohol, caffeine, nicotine, medication use, and other pre-session restrictions
排除标准
- •History of head injury or epilepsy or seizure disorders
- •Current or past major psychiatric, neurological, or serious medical illness that may affect participant safety or study outcomes
- •Current use of psychoactive medications, hormonal medications, or other medications that may substantially affect central nervous system or neuroendocrine function
- •Regular smoking or inability to comply with the required nicotine abstinence period before testing
- •Face recognition impairment or other visual-perceptual impairment that could interfere with performance of the emotional face tasks
研究组 & 干预措施
Arginine Vasopressin (AVP) Group
Participants assigned to this arm receive a single 24 IU dose of arginine vasopressin (AVP) via a lyophilized oromucosal lollipop before completing the fMRI emotional attention tasks.
干预措施: Arginine Vasopressin (AVP) (Drug)
Placebo (PLC) Group
Participants assigned to this arm receive placebo (PLC) via a matched lyophilized oromucosal lollipop before completing the fMRI emotional attention tasks.
干预措施: Placebo (PLC) (Drug)
oxytocin (OT) group
Participants assigned to this arm receive a single 24 IU dose of oxytocin (OT) via a lyophilized oromucosal lollipop, followed by the scheduled post-treatment procedures and fMRI emotional attention tasks.
干预措施: Oxytocin (OT) (Drug)
结局指标
主要结局
Behavioral Performance in the Emotional Face Attention Tasks
时间窗: During the fMRI task session, approximately 1 hour
Behavioral performance will be assessed using correct response time and response accuracy during the emotional face attention tasks. Analyses will examine treatment-related effects across the oxytocin (24 IU), arginine vasopressin (24 IU), and placebo groups within the top-down and bottom-up attention tasks and under high and low attentional load. Primary analyses will evaluate treatment effects and treatment-by-task-condition interactions on reaction time and accuracy. Direct comparisons among OT, AVP, and placebo will be used to characterize shared and differential behavioral effects of the two neuropeptides. For oxytocin, the behavioral effects observed following oromucosal administration will be interpreted with reference to previously reported intranasal findings using the same or a conceptually related attentional framework. Particular emphasis will be placed on whether the direction and condition dependence of effects on reaction time and accuracy show qualitative consistency.
BOLD Responses in Predefined Brain Regions and Networks
时间窗: During the fMRI task session, approximately 1 hour
Task-evoked BOLD responses will be measured using fMRI during the emotional face attention tasks. Primary neuroimaging analyses will examine treatment-related effects within predefined regions of interest and neural networks implicated in emotional salience, attentional control, emotional face processing, and social neuropeptide processing. Regions of interest will be defined independently of the present treatment effects using anatomical definitions and/or prior literature. Treatment effects and treatment-by-task-condition interactions will be assessed across the oxytocin, arginine vasopressin, and placebo groups during top-down and bottom-up attention and under high and low attentional load. Complementary whole-brain analyses will be conducted to identify treatment-related neural effects outside the predefined regions and to characterize broader patterns of task-evoked modulation.
次要结局
- Peripheral Oxytocin and Arginine Vasopressin Levels(Before treatment administration and approximately 30 minutes after administration)
研究者
Shuxia Yao
Associate Professor
University of Electronic Science and Technology of China