Effect of Oral Oxytocin of Brain and Behavioral Responses to Emotional Stimuli in Healthy Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Effects of oral oxytocin on behavioral ratings of emotional faces stimuli
研究概览
简要总结
The main aim of the study is to investigate whether orally administered oxytocin (24IU) could modulate females' neural and behavioral responses to affective stimuli including emotional faces and affective scenes.
详细描述
All subjects will complete a series of questionnaires firstly to control for possible pre-treatment confounders in terms of personality traits and mood: Beck Depression Inventory-II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), the Second Version of Social Responsiveness Scale(SRS-2), Positive and Negative Affect Schedule (PANAS). PANAS is administered before and after oral administration and after functional magnetic resonance imaging (fMRI) scanning. In the current double-blind, between-subject, placebo-controlled study 80 healthy female subjects will be recruited and receive oral administration either oxytocin (24IU) or placebo. Blood samples are collected twice before and 30 minutes after oral administration to assess the plasma OXT concentrations change. 45 minutes after oral administration subjects will be required to finish fMRI scanning including resting-state fMRI task, emotional face task (happy, fear, angry and neutral faces), affective scene task (NAPS, Nencki affective picture system, positive, neutral, and negative-valence scenes). After fMRI scanning, subjects will be required to rate valence, intensity, and arousal responses (Likert scale, 1-9 ratings) to the emotional and affective stimuli are presented during fMRI scanning.
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 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects without any past or present psychiatric or neurological disorders
排除标准
- •History of brain injury
- •Head trauma
- •Substance abuse
- •Medication
- •fMRI contraindications (e.g. metal implants)
研究组 & 干预措施
Oral Oxytocin
Oxytocin orally (24 IU)
干预措施: Oral Oxytocin (Drug)
Oral Placebo
Placebo orally (identical ingredients, except the active agent)
干预措施: Oral Placebo (Drug)
结局指标
主要结局
Effects of oral oxytocin on behavioral ratings of emotional faces stimuli
时间窗: 45 minutes after treatment
Differences in behavioral ratings of valence(1-9-point Likert scale, 1 means very negative,9 means very positive, 5 means neutral), intensity (1-9-point Likert scale, 1 means mild, 9 means strong), and arousal(1-9-point Likert scale, 1 means sleepy, 9 means alert) for emotional faces stimuli between oxytocin group and placebo group.
Effects of oral oxytocin on neural responses to affective scenes assessed by affective scenes processing task fMRI
时间窗: 45 minutes after treatment
Comparison of neural activations as assessed by functional MRI on the whole-brain level between oral oxytocin and placebo by means of treatment (oxytocin, placebo) × scenes(neutral, positive, negative) ANOVA and scene-specific post-hoc comparisons between the treatment groups.
Effects of oral oxytocin on neural responses to emotional faces assessed by emotional faces processing task fMRI
时间窗: 45 minutes after treatment
Comparison of neural activations between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo)× faces(happy, neutral, angry, fear) ANOVA and emotional face-specific post-hoc comparisons between the treatment groups.
Changes in blood oxytocin concentrations after oral oxytocin
时间窗: Before and 30 minutes after treatment
Changes in blood oxytocin concentrations will be assessed across two groups between baseline and 30 minutes after oral treatment administration.
Effects of oral oxytocin on behavioral ratings of affective scenes stimuli
时间窗: 45 minutes after treatment
Differences in behavioral ratings of valence(1-9-point Likert scale, 1 means very negative,9 means very positive, 5 means neutral), intensity (1-9-point Likert scale, 1 means mild, 9 means strong), and arousal(1-9-point Likert scale, 1 means sleepy, 9 means alert) of affective scenes stimuli between oxytocin group and placebo group.
次要结局
- Gender differences in behavioral responses to affective scenes stimuli(45 minutes after treatment)
- Interaction effect between gender and treatment on neural response to emotional faces stimuli(45 minutes after treatment)
- The relationship between plasma oxytocin concentrations changes and neural responses to affective scenes stimuli(Before treatment to 150 minutes after treatment)
- Gender differences in plasma oxytocin concentrations changes(Before and 30 minutes after treatment)
- The relationship between plasma oxytocin concentrations changes and behavioral responses to emotional faces stimuli(Before treatment to 150 minutes after treatment)
- The relationship between plasma oxytocin concentrations changes and behavioral responses to affective scenes stimuli(Before treatment to 150 minutes after treatment)
- Gender differences in behavioral responses to emotional faces stimuli(45 minutes after treatment)
- Interaction effect between gender and treatment on plasma oxytocin concentrations changes(Before and 30 minutes after treatment)
- Gender differences in neural response to affective scenes stimuli(45 minutes after treatment)
- Interaction effect between gender and treatment on behavioral responses to emotional faces stimuli(45 minutes after treatment)
- The relationship between plasma oxytocin concentrations changes and neural responses to emotional faces stimuli(Before treatment to 150 minutes after treatment)
- Gender differences in neural response to emotional faces stimuli(45 minutes after treatment)
- Interaction effect between gender and treatment on neural response to affective scenes stimuli(45 minutes after treatment)
- Interaction effect between gender and treatment on behavioral responses to affective scenes stimuli(45 minutes after treatment)
研究者
Keith Kendrick
Principal Investigator
University of Electronic Science and Technology of China