跳至主要内容
临床试验/NCT05968651
NCT05968651已完成2 期

Social Safety Learning in the Brain Oxytocin System

University of Washington2 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2023年6月26日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
121
试验地点
2
主要终点
neural responses (e.g., regional brain activation in the ventromedial prefrontal cortex (vmPFC) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement

研究概览

简要总结

The investigators are conducting this research study to examine whether oxytocin enhances social safety learning (learning safety through the experience of another individual) in people with social anxiety disorder (SAD) compared to healthy volunteers. Oxytocin is a hormone that can also act as a chemical messenger in the brain. Oxytocin plays a role in a number of functions, including responding to fear and social interactions. In this study, the investigators would like to compare the effects of oxytocin and placebo nasal sprays in adults with SAD and healthy adults. This research study will compare an oxytocin nasal spray to a placebo nasal spray. About 120 people will take part in this research study, all at the University of Washington (UW).

详细描述

The goal of the current study is to examine the potential role of oxytocin in enhancing social learning in SAD. The investigators' primary hypothesis is that vicarious extinction learning will contribute to safety learning and that oxytocin will potentiate vicarious extinction learning in patients with SAD, compared to healthy controls (HC). The investigators will directly test the effect of intranasal oxytocin and matching placebo on the brain mechanisms underlying vicarious extinction learning using a novel task. 60 adults with SAD and 60 healthy control participants will perform a task that involves three phases: (i) a standard social fear acquisition procedure while in a mock scanner, followed by (ii) a vicarious extinction and (iii) fear reinstatement test procedure, while being scanned during functional magnetic resonance imaging (fMRI). Participants will receive oxytocin or placebo prior to the extinction phase. The investigators will also measure skin conductance responses as an index of learning in each phase.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • For Clinical Sample
  • Men and women age 18-45
  • Women must be having regular menstrual cycles and not be taking oral contraception
  • Primary diagnosis of social anxiety disorder
  • For Healthy Sample
  • Men and women age 18-45
  • Women must be having regular menstrual cycles and not be taking oral contraception
  • No current or lifetime history of psychiatric, neurological, or medical disorders

排除标准

  • For All Groups
  • Pregnancy or breastfeeding
  • Positive urine drug screening test result
  • History of nasal pathology
  • Current use of any psychotropic medication or steroids
  • Active substance use disorder within the past 6 months
  • History of serious medical illnesses or untreated endocrine diseases
  • History of head injury, neurological disorder, or neurosurgical procedure
  • Positive magnetic resonance (MR) screen
  • For Clinical Sample
  • Lifetime diagnoses of mania or psychotic disorder based on the Diagnostic and Statistical Manual (DSM- 5th ed)
  • Acute suicidal ideation
  • For Healthy Sample
  • Lifetime DSM-5 diagnosis of any medical, neurological, or psychiatric illness

结局指标

主要结局

neural responses (e.g., regional brain activation in the ventromedial prefrontal cortex (vmPFC) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement

时间窗: immediately after the intervention

vmPFC blood oxygen level dependent (BOLD) responses for non-reinforced conditioned stimulus (CS-) versus reinforced conditioned stimulus (CS+)

次要结局

  • skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement(immediately after the intervention)

研究者

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

Angela Fang

Assistant Professor, Department of Psychology

University of Washington

研究点 (2)

Loading locations...

相似试验