The Interaction Between Oxytocin and Serotonin on the Social-emotional Brain Networks
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neural processing during the resting state as assessed via fMRI
研究概览
简要总结
the study aims to explore whether there is an interaction between oxytocin and serotonin in the regulation of emotion-based behavior by using a between-subject randomized double blind pharmacological fMRI design during which 4 groups of healthy male subjects will receive combinations of oxytocin nasal-spray (versus placebo) and acute tryptophan depletion (ATD, versus placebo)
详细描述
Convergent evidence from animal models and human studies suggests that both, serotonin and oxytocin are important regulators of social emotional behavior. Evidence is emerging that both systems interact in this domain. To determine the interaction of both systems on human social behavior, the present study aims to combine a randomized placebo-controlled administration of modulators of both systems (Oxytocin nasal-spray and acute tryptophan depletion, ATD) and their combination within a pharmaco-fMRI experiment. To determine effects on the neural networks engaged in social emotional processing, healthy male subjects will receive single doses of oxytocin (24IU) versus placebo and ATD (75.2g) versus placebo before fMRI measures of emotion perception and resting state will be acquired. To control for potential effects of pre-medication personality traits as well as effects of medicines on mood, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of mood.
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
- Double (Participant, Investigator)
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
- •health subjects without past or current psychiatric or neurological disorders
- •Right-handedness
排除标准
- •History of head injury;
- •Medical or psychiatric illness.
- •High blood pressure, general cardio-vascular alterations
- •History of drug or alcohol abuse or addiction.
- •Allergy against medications or general strong allergies
- •Sleep disorders.
- •Visual or motor impairments
研究组 & 干预措施
male oxytocin and ATD group
male subjects receiving oxytocin and ATD treatment
干预措施: oxytocin nasal spray (Drug)
male oxytocin and ATD group
male subjects receiving oxytocin and ATD treatment
干预措施: ATD treatment (Drug)
male oxytocin and placebo group
male subjects receiving oxytocin and ATD-placebo treatment
干预措施: oxytocin nasal spray (Drug)
male oxytocin and placebo group
male subjects receiving oxytocin and ATD-placebo treatment
干预措施: oral placebo treatment (placebo-control for ATD) (Drug)
male placebo and ATD group
male subjects receiving oxytocin placebo and ATD treatment
干预措施: intranasal placebo treatment (placebo-control for oxytocin) (Drug)
male placebo and ATD group
male subjects receiving oxytocin placebo and ATD treatment
干预措施: ATD treatment (Drug)
male placebo group
male subjects receiving oxytocin placebo and ATD placebo treatment
干预措施: intranasal placebo treatment (placebo-control for oxytocin) (Drug)
male placebo group
male subjects receiving oxytocin placebo and ATD placebo treatment
干预措施: oral placebo treatment (placebo-control for ATD) (Drug)
结局指标
主要结局
Neural processing during the resting state as assessed via fMRI
时间窗: 6h after treatment
Resting state activity in the emotional brain networks will be compared between the treatment groups
Neural processing during the emotion processing as assessed via fMRI
时间窗: 6h after treatment
fMRI BOLD indices of neural processing in emotion related brain regions will be compared between the treatment groups
次要结局
未报告次要终点
研究者
Benjamin Becker
Professor
University of Electronic Science and Technology of China