Differential Modulation of Neural and Behavioral Responses to Emotional Scenes by Intranasal and Oral Oxytocin Administration in Healthy Men
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Compare the effects of oxytocin on behavioral responses to emotional scenes between intranasal and oral administration routes.
研究概览
简要总结
The study will investigate whether oxytocin administered either intranasally or orally (lingual) (24 international units, IU) can differentially modulate men's neural and behavioral responses to emotional scenes using an implicit emotional paradigm.
详细描述
Previous studies have reported that oxytocin administration intranasally and orally (spray on the tongue) can modulate neural and behavioral responses during processing of face emotions and can influence top-down attention to social stimuli. However, no research has directly compared the neural and behavioral effects of the two different administration routes on the processing of emotional scenes. In the current randomized, double-blind, between-subjects, placebo-controlled study, 160 healthy male subjects will be recruited and receive treatment either oxytocin (24IU, orally/intranasally) or placebo (orally/intranasally). Prior to treatment, all subjects will complete a number of questionnaires to control for potential group differences in potential confounders in terms of personality traits and mood, including: Beck Depression Inventory-II (BDI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS), State-Trait Anxiety Inventory (STAI), Childhood Trauma Questionnaire (CTQ), Interpersonal Reactivity Index (IRI). Additionally, the Positive and Negative Affect Schedule (PANAS) is administered before the treatment and before and after completing the implicit emotional scanning task to measure any changes in mood. Forty-five minutes after receiving treatment, subjects will be required to undergo and MRI scanning session including structural scans and resting-state fMRI followed by an implicit emotional scene processing task (picture source: Nencki affective picture system, including positive, neutral, and negative-valence social and non-social scenes). After fMRI scanning, subjects will be required to rate emotional stimuli presented during the scan on valence, intensity, and arousal using 1-9 point Self-Assessment Manikin (SAM) scales.
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
- Male
- 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
研究组 & 干预措施
Oral Oxytocin
Administer oxytocin (24 IU) orally
干预措施: Oral Oxytocin (Drug)
Intranasal Oxytocin
Administer oxytocin (24 IU) intranasally
干预措施: Intranasal Oxytocin (Drug)
Oral placebo
Administer placebo orally (identical ingredients, except the active agent)
干预措施: Oral placebo (Drug)
Intranasal placebo
Administer placebo intranasally (identical ingredients, except the active agent)
干预措施: Intranasal placebo (Drug)
结局指标
主要结局
Compare the effects of oxytocin on behavioral responses to emotional scenes between intranasal and oral administration routes.
时间窗: 70~90 minutes after treatment
Differences in behavioral ratings of valence (1-9 point Self-Assessmen-Manikin (SAM) scale, 1 means very negative, 9 means very positive, 5 means neutral), intensity (1-9 point SAM scale, 1 means mild, 9 means strong), and arousal (1-9 point SAM scale, 1 means not aroused at all, 9 means very aroused) of emotional scene stimuli between oral oxytocin and intranasal oxytocin groups will be examined using mixed ANOVAs, respectively.
Compare the effects of oxytocin on neural responses to emotional scenes between intranasal and oral administration routes.
时间窗: 45~70 minutes after treatment
Comparison of whole brain neural (fMRI scanning) activation differences between oral and intranasal oxytocin administration to emotional scenes will be performed using a mixed ANOVA with route (oral/intranasal), treatment (oxytocin/placebo) as between subject factors and valence of emotional scenes (positive/negative/neutral) as within-subject factor, post-hoc comparisons will be conducted to further disentangle the significant interactions observed after the mixed ANOVA.
次要结局
- Correlations between neural activation and behavioral effects of intranasal or oral oxytocin during emotional scene processing.(45~90 minutes after treatment)
- Correlations between functional connectivity and behavioral effects of intranasal or oral oxytocin during emotional scene processing.(45~90 minutes after treatment)
- Comparison of effects of oxytocin on pre-task resting-state functional connectivity (rsfMRI) between intranasal and oral administration routes.(45~70 minutes after treatment)
- Mood changes assessed by the Positive Affect Negative Affect Schedule (PANAS) in all treatment groups during the experiment.(0~70 minutes)
- Compare the effect of oxytocin on neural functional connectivity during processing of emotional scenes between intranasal and oral administration routes.(45~70 minutes after treatment)
