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临床试验/NCT01823146
NCT01823146已完成不适用

Oxytocin and Aging: Neuro-Behavioral Effects on Social Cognition and Prosocial Behavior

University of Florida1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2013年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
Extent of Trust Behavior

研究概览

简要总结

This study will investigate the extent to which intranasal oxytocin affects changes in social decision making and evaluations of others. Oxytocin is a hormone that naturally occurs in the body and the brain and has been shown to be relevant for many behaviors, particularly in social situations. Research on the effects of oxytocin in aging is very scarce; therefore, the purpose of this research project is to determine the effects of oxytocin on socioemotional aging.

详细描述

In order to demonstrate oxytocin as a causal mechanism in socioemotional aging, the investigators propose to temporarily elevate oxytocin levels and then measure activity in the brain while participants engage in socially relevant tasks. Participants in this study will be randomly assigned (much like flipping a coin) to receive either a single administration of oxytocin or a placebo (a substance that looks like the oxytocin but does not have any active drug). Neither participants nor the investigator will know to which condition each participant is assigned. Prior to being enrolled into the study a screening to determine eligibility will be conducted. Once the screening visit is completed and it has been determined that subjects can be randomized into the study, an appointment will be scheduled for the full study visit.

The purpose of the screening is to determine whether the individual is eligible for participation in the study and will consist of a series of questions about demographics and health history, two saliva samples, two short tasks, blood test, and brief meeting with a licensed clinician to ensure that it is safe for the individual to take part in the magnetic resonance imaging (MRI) and drug administration.

The study visit will comprise two collections of saliva for laboratory tests prior to and following the oxytocin administration in order to measure levels of the hormone in the body at baseline and after the spray. Saliva samples will also allow for an examination of how oxytocin-related genes may impact cognition and behavior during study tasks. Participants will work on various social tasks while in the MRI scanner, and response accuracy, response time, and brain activity will be recorded. After the scan, participants will complete a series of brief questionnaires on paper and on the computer.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18-30 years or 63-85 years
  • English fluency
  • Caucasian
  • Right-handed

排除标准

  • Pregnant or possibly pregnant
  • Breastfeeding
  • Claustrophobia
  • Currently on vasoconstrictors, pseudoephedrine or antidiuretic medication
  • Large pieces of metal in the body, particularly in the face or neck
  • Piercings or metal implants that cannot be removed from the body
  • Surgery on the brain or any prior serious brain damage or disease
  • Dementia or severe cognitive disorders
  • History of hyponatremia, Syndrome of Inappropriate Antidiuretic Hormone, psychogenic polydipsia, or motion disorder

研究组 & 干预措施

Oxytocin spray

Experimental

single dose of 24 IU oxytocin, self-administered intranasally (IN)

干预措施: Oxytocin spray (Drug)

Placebo spray

Placebo Comparator

single dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN)

干预措施: Placebo spray (Drug)

结局指标

主要结局

Extent of Trust Behavior

时间窗: 45 minutes after drug/placebo administration

Average amount of monetary units invested in the context of the Trust/Lottery Game. The theoretical range was 0 to 72 monetary units across all 24 trials. Participants invested in 12 social (human person) and 12 non-social (computer) trials.The mean average amount of monetary units invested was calculated for social and non-social trials separately.

次要结局

  • Meta-Mood(2.5 hours after drug/placebo administration)
  • Functional Connectivity (Resting fMRI)(1.5 hours after oxytocin/placebo administration)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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