Oral Oxytocin Modulation of Brain and Behavioral Responses to Emotional Stimuli in Healthy Men
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
- Effect of oral oxytocin administration of oxytocin on neural responses to positive and negative valence emotional faces, as assessed by task fMRI
研究概览
简要总结
The main aim of the study is to investigate whether orally administered oxytocin (24IU) can modulate neural and behavioral responses to positive and negative valence stimuli during basal (emotional scenes) and higher order (facial stimuli) emotional processing.
详细描述
A number of previous studies have reported both neural and social cognition effects of intranasally administered oxytocin, although it is unclear whether functional effects are mediated by the peptide directly entering the brain or indirectly via raising peripheral concentrations. The investigators hypothesize that one method of producing a similar pattern of increased peripheral oxytocin concentrations but without the possibility of direct entry into the brain would be to administer the peptide lingually. In the current double-blind, between-subject, placebo controlled study 80 healthy male subjects will be recruited and receive either oxytocin (24IU) or placebo control administered orally (lingual). 45 minutes after treatment subjects will be required to complete both face emotion and emotional scene processing tasks during fMRI scanning. After the tasks, subjects will be required to rate their valence, intensity and arousal response to the same emotional face and scene stimuli which were presented during MRI acquisition. Blood samples will be taken before and 30 min after the oral treatment interventions to assess oxytocin blood concentrations. All subjects will be asked to complete a range of questionnaires before treatment 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), and Interpersonal Reactivity Index (IRI).
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
- 17 Years 至 32 Years（Child, 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
- •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
Effect of oral oxytocin administration of oxytocin on neural responses to positive and negative valence emotional faces, as assessed by task fMRI
时间窗: 45-90 minutes after treatment
Comparison of neural activation as assessed by functional MRI on the whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (happy, neutral, angry, fear) ANOVAs and emotion-specific comparisons between the treatment groups. We hypothesized that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.
Effect of oral oxytocin administration on neural responses to positive and negative valence scenes, as assessed by fMRI
时间窗: 45-90 minutes after treatment
Comparison of neural activation as assessed by functional MRI on whole brain level between oral administration of oxytocin and placebo by means of treatment (oxytocin, placebo) x emotion (neutral, positive, negative) ANOVAs and emotion-specific post hoc comparisons between the treatment groups. We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on neural systems involved in emotional and brain reward processing. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively a different pattern of functional effects.
Effect of oral oxytocin administration on behavioral ratings of face emotion and scene stimuli
时间窗: 45-115 minutes after treatment
Comparison of behavioral ratings of valence, arousal and intensity (9-point Likert scale) for emotional face and social scene stimuli presented again post-scan will be performed in oxytocin versus placebo control groups. We hypothesize that if the effects of oxytocin administration reported following intranasal administration are primarily produced via an increase in peripheral concentrations then oral administration should produce similar effects on behavioral ratings of positive and negative valence emotional stimuli. If on the other hand some, or all, of the effects of intranasal oxytocin are mediated via a direct action on the brain then oral administration should result in either no effect or alternatively in a different pattern of functional effects.
Change in blood oxytocin concentrations following oral administration of oxytocin
时间窗: 30 minutes before treatment and 30 minutes after treatment
Changes in blood concentrations of oxytocin from baseline after oral oxytocin treatment will be assessed by comparison with the placebo group. We hypothesize that oral oxytocin should produce a significant increase in blood oxytocin concentrations after 30 minutes.
次要结局
- Correlations between neural responses/functional connectivity changes and post-scan behavioral ratings(45-115 minutes after treatment)
- Correlations between neural responses/functional connectivity in response to positive and negative valence stimuli and basal and oral administration evoked changes in blood concentrations of oxytocin(30 minutes before treatment to 90 minutes after treatment)
- Correlations between behavioral ratings of positive and negative valence stimuli and basal and oral administration evoked changes in blood oxytocin concentrations(30 minutes before treatment to 115 minutes after treatment)
研究者
Keith Kendrick
Principal Investigator
University of Electronic Science and Technology of China