Multiple Dose Effect of Oxytocin on Males With High or Low Trait Anxiety
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI
研究概览
简要总结
To examine whether multiple doses of oxytocin have different effects on behavior and neural indices in males with high or low trait anxiety.
详细描述
In the present study, healthy male subjects' trait anxiety levels will be assessed by the sub-trait inventory of the State-Trait Anxiety Inventory (STAI). According to subjects' trait anxiety scores, they will be divided into high or low anxiety experimental groups.
Next, experiments will investigate the acute effect (single dose) and chronic effect (3 doses or 5 doses) of oxytocin on brain functional connectivity during resting-state and brain activation in response to watching emotional stimuli using functional magnetic resonance imaging (fMRI). Also the brain structure data (T1 and diffusion tensor imaging, DTI) of subjects will be collected. After finishing the scanning tasks, subjects will be required to rate the emotional valence, intensity and arousal of the pictures shown in the scanner.
During the course of the study subjects will complete a number of questionnaires: Empathy Quotient (EQ), Cheek and Buss Shyness scale (CBSS),Interpersonal Reactivity Index (IRI),Childhood Trauma Questionnaire (CTQ),Beck depression inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Liebowitz Social Anxiety Scale (LSAS),Positive and Negative Affect Schedule (PANAS),d2 attention test, and the Visual Analogue Scale for anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
High anxiety group (single dose)
Oxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety.
干预措施: Oxytocin nasal spray (Drug)
High anxiety group (single dose)
Oxytocin nasal spray or placebo nasal of one dose in subjects with high trait anxiety.
干预措施: Placebo nasal spray (Drug)
High anxiety group (3 doses)
Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with high trait anxiety.
干预措施: Oxytocin nasal spray (Drug)
High anxiety group (3 doses)
Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with high trait anxiety.
干预措施: Placebo nasal spray (Drug)
High anxiety group (5 doses)
Oxytocin nasal spray or placebo nasal spray for 5 days,24 IU per day in subjects with high trait anxiety.
干预措施: Oxytocin nasal spray (Drug)
High anxiety group (5 doses)
Oxytocin nasal spray or placebo nasal spray for 5 days,24 IU per day in subjects with high trait anxiety.
干预措施: Placebo nasal spray (Drug)
Low anxiety group (single dose)
Oxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety.
干预措施: Oxytocin nasal spray (Drug)
Low anxiety group (single dose)
Oxytocin nasal spray or placebo nasal spray of one dose in subjects with low trait anxiety.
干预措施: Placebo nasal spray (Drug)
Low anxiety group (3 doses)
Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with low trait anxiety.
干预措施: Oxytocin nasal spray (Drug)
Low anxiety group (3 doses)
Oxytocin nasal spray or placebo nasal spray interleaved during the 5 days( on the 1st,3rd and 5th day),24 IU per day in subjects with low trait anxiety.
干预措施: Placebo nasal spray (Drug)
Low anxiety group (5 doses)
Oxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety.
干预措施: Oxytocin nasal spray (Drug)
Low anxiety group (5 doses)
Oxytocin nasal spray or placebo nasal spray for 5 days in subjects with low trait anxiety.
干预措施: Placebo nasal spray (Drug)
结局指标
主要结局
Changes between acute and chronic administration of oxytocin on amygdala connectivity as assessed by fMRI
时间窗: 5 days
Changes in neural connectivity between first dose and repeated dose will be assessed over the time course of 5 days
Changes between acute and chronic administration of oxytocin on amygdala activity as assessed by fMRI
时间窗: 5 days
Changes in neural activity between first dose and repeated dose will be assessed over the time course of 5 days
次要结局
- Interaction of acute and chronic treatment effects with trait anxiety on neural activity(5 days)
- Interaction of acute and chronic treatment effects with trait anxiety on neural connectivity(5 days)
- Interaction of treatment effects on arousal ratings with trait anxiety (acute and changes with chronic treatment)(5 days)
- Effects of oxytocin on arousal ratings of emotional stimuli (acute and changes with chronic treatment)(5 days)
- Effects of oxytocin on valence ratings of emotional stimuli (acute and changes with chronic treatment)(5 days)
- Interaction of treatment effects on valence ratings with trait anxiety (acute and changes with chronic treatment)(5 days)
研究者
Keith Kendrick
Professor
University of Electronic Science and Technology of China