Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin
2017年1月3日 更新者：Rene Hurlemann、University Hospital, Bonn
The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala response vary as a function of treatment dose and dose-test latency.
研究概览
详细说明
The objective of the present study is to determine whether intranasal oxytocin (IN-OXT) effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD fMRI) in the amygdala vary as a function of dose and latency.
In particular, the investigators plan to compare effects of three different IN-OXT doses (12, 24, and 48 international units, IU) and three different dose-test latencies of IN-OXT administration (task starting at 15, 45 and 75min after administration) on established neural and behavioural correlates of emotion processing.
As effects of OXT are particularly promising in autism, the investigators further want to investigate how autistic-like traits influence the OXT effects in exploratory post-hoc analyses
研究类型
介入性
注册 (实际的)
116
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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North Rhine-Westphalia
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Bonn、North Rhine-Westphalia、德国、53105
- Department of Psychiatry, University of Bonn
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- Healthy male volunteers
- Right-handed
Exclusion Criteria:
- Current or past psychiatric disease
- Current or past physical illness
- Psychoactive medication
- Tobacco smokers
- MRI contraindication (e.g. metal in body, claustrophobia)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Oxytocin; 24IU, 15min
Intranasal administration, 24 international units (IU) oxytocin.
Imaging starting 15min after nasal spray administration.
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有源比较器：Oxytocin; 24IU, 45min
Intranasal administration, 24 IU oxytocin.
Imaging starting 45min after nasal spray administration.
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有源比较器：Oxytocin; 24IU, 75min
Intranasal administration, 24 IU oxytocin.
Imaging starting 75min after nasal spray administration.
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有源比较器：Oxytocin; 12IU, 45min
Intranasal administration, 12 IU oxytocin.
Imaging starting 45min after nasal spray administration
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有源比较器：Oxytocin; 48IU, 45min
Intranasal administration, 48 IU oxytocin.
Imaging starting 45min after nasal spray administration
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安慰剂比较：Placebo
Placebo nasal spray.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Neural substrates of emotion processing, measured via blood-oxygen-level dependent signal in the amygdala
大体时间：45min after nasal spray administration
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Magnetic resonance imaging (MRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli of varying intensity. The investigators specifically plan to investigate amygdala response to fearful faces, as this subcortical region has repeatedly been reported to show activation changes after OXT treatment. Dose-test latency varies between the different treatment arms (i.e. imaging starts 15min [arm 1], 45min [arm 2,4 and 5] or 75min [arm 3] after nasal spray administration). |
45min after nasal spray administration
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Ratings of emotional faces
大体时间：45min after nasal spray administration
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During each trial, subjects are asked to use a button response grip to indicate whether they perceived the depicted face as neutral, fearful or happy. Depending on the treatment arm, ratings are recorded 15min (arm 1), 45min (arm 2,4 and 5) or 75min (arm 3) after nasal spray administration. |
45min after nasal spray administration
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Questionnaire measurement of mood (PANAS)
大体时间：10 min before and 105 min after nasal spray administration
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Positive and negative affect is assessed via self-rating questionnaire 'The Positive and Negative Affect Schedule' using a categorical 5 point scale.
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10 min before and 105 min after nasal spray administration
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Questionnaire measurement of anxiety (STAI).
大体时间：10 min before and 105 min after nasal spray administration
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State anxiety is assessed via self-rating questionnaire 'and State Trait Anxiety Inventory' using a categorical 4 point scale.
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10 min before and 105 min after nasal spray administration
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Saliva oxytocin concentrations
大体时间：immediately before the nasal spray administration and (on average) 15,40,80 and 105 min after administration
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immediately before the nasal spray administration and (on average) 15,40,80 and 105 min after administration
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Plasma oxytocin concentrations
大体时间：immediately before the nasal spray administration and immediately after the fMRI experiment
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immediately before the nasal spray administration and immediately after the fMRI experiment
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Modulatory effects of autistic like traits on neural and behavioral outcome measures
大体时间：screening session, ~7days prior to imaging session
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Autistic like traits are assessed via Autism Spectrum quotient in a screening session, preceding the testing sessions.
The investigators expect pronounced OXT effects in subjects with high autistic-like traits.
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screening session, ~7days prior to imaging session
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年9月1日
初级完成 (实际的)
2015年12月1日
研究完成 (实际的)
2016年2月1日
研究注册日期
首次提交
2016年12月12日
首先提交符合 QC 标准的
2017年1月3日
首次发布 (估计)
2017年1月6日
研究记录更新
最后更新发布 (估计)
2017年1月6日
上次提交的符合 QC 标准的更新
2017年1月3日
最后验证
2017年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
安慰剂的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的