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临床试验/NCT02394054
NCT02394054已完成早期 1 期

Vasopressin's Effect on Behavior and Neural Activity During Social Cognition Tasks

University of California, Los Angeles1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
84
试验地点
1
主要终点
Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion

研究概览

简要总结

It has long been established that interpersonal relationships can have a profound impact on health and well-being. Yet, the investigators are still learning about the complex biological processes that contribute to positive social interactions and the ability to develop and maintain social relationships. Recent research has begun to focus on vasopressin, a neuropeptide that is naturally produced in the hypothalamus, because administration of this neuropeptide has been associated with empathy, cooperation, memory of social stimuli (e.g., faces), and brain activity in neural regions associated with social and emotional processes. To date, several aspects of vasopressin's effects on social behavior have been unexplored. As such, the overarching goal of this project is to examine the effects of intranasal vasopressin on several tasks involving learning and social processes. In addition, the investigators will explore associated neural activity through functional magnetic resonance imaging (fMRI). Results from the study will inform our understanding of the neurobiology of socioemotional processes.

The investigators hypothesize that compared to placebo, vasopressin will improve deception detection, increase empathy and altruism, enhance responses to photo stimuli of primary caregivers, and improve learning when the subject has a prosocial goal of teaching another person. These effects will manifest in behavioral and neural activity. It is also hypothesized that main effects will not be found for vasopressin, but rather, analyses of relevant moderators will elucidate these findings.

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
All
接受健康志愿者

入选标准

  • 18-30 years of age
  • Healthy (see below)
  • Fluent in English
  • Right-handed

排除标准

  • Women who gave birth in the last six months, are currently pregnant, planning to become pregnant in the next 6 months, or currently breastfeeding women
  • Symptoms of runny nose due to allergies/cold or other reason
  • Current restricted fluid intake for any reason
  • Heart disease
  • Hypertension
  • History of myocardial infarction
  • History of cardiac arrhythmia
  • Kidney or liver disease
  • Vascular disease
  • Nephritis
  • Diabetes and other endocrine diseases
  • Frequent or unexplained fainting
  • History of stroke
  • Aneurysm or brain hemorrhage
  • Active psychiatric diagnosis
  • Current psychopharmacologic treatment
  • Drug or alcohol abuse
  • Medical or neurological illness
  • Regular use of medication (e.g., vasoconstrictive medications)
  • Medication intake less than 2 weeks prior to study (5 weeks for fluoxetine) including daily non-steroidal anti-inflammatory drugs
  • Smoking more than 15 cigarettes a day
  • Consumption of any alcoholic beverages in the past 24 hours will be excluded
  • Elevated blood pressure (>135/90)
  • Low blood pressure (<90/55)
  • Body temperature >100.1 F
  • Left-handed
  • Claustrophobia
  • Presence of metal in their body

研究组 & 干预措施

Intranasal vasopressin

Experimental

Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).

干预措施: Intranasal vasopressin (Drug)

Intranasal placebo

Placebo Comparator

2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter. Participants will self-administer 5 puffs per nostril.

干预措施: Intranasal placebo (Drug)

结局指标

主要结局

Changes in neural brain activity, as observed by fMRI, when observing others during social inclusion vs. exclusion

时间窗: Between 40-115 minutes post administration

Whole brain and region of interest (ROI) regression analysis will be used to compare the neural activity of participants in the vasopressin/placebo groups. A design matrix will be created for each participant, modeling activity that is greater during the exclusion portion of the cyberball task (Williams et al., 2012) versus the inclusion portion. A first-level analysis will compare \[(friend exclusion\>friend inclusion)\>(stranger exclusion\>stranger inclusion)\] for each participant. A second-level group analysis will compare these first-level contrasts between the vasopressin and placebo groups.

次要结局

  • Altruism and punishment as measured by number of points given to excluders and those excluded(Between 40-115 minutes post administration)
  • Changes in neural brain activity, as observed by fMRI, when viewing images of primary caregivers versus strangers(Between 40-115 minutes post administration)
  • Ratings of empathic concern after witnessing social exclusion in a friend or a stranger(Between 40-115 minutes post administration)
  • Changes in brain neural activity, observed by fMRI, in response to a reading comprehension task(Between 40-90 minutes post administration)
  • Performance on a memory test of reading comprehension as measured by percentage of questions answered correctly(Between 40-90 minutes post administration)
  • Changes in neural brain activity, as observed by fMRI, while attempting to detect deception(Between 40-115 minutes post administration)
  • Accuracy of deception detection as measured by self-report(Between 40-115 minutes post administration)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Lieberman

Matthew D. Lieberman, PhD

University of California, Los Angeles

研究点 (1)

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