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临床试验/NCT03335085
NCT03335085已完成不适用

Long-term Consequences of Childhood Adversity: Exploring Stress Responsive Molecular Pathways and Psychobiological Intervention Models

Ruhr University of Bochum0 个研究点目标入组 80 人开始时间: 2011年7月1日最近更新:
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
发起方
入组人数
80
主要终点
Reading the Mind in the Eyes Test

研究概览

简要总结

This study evaluates whether intranasal administration of a single dose of oxytocin improves the ability to recognize emotional states. In a cross-over design, half of the participants first received oxytocin, the other half first received placebo.

详细描述

Adverse childhood experience such as neglect or abuse can lead to long-term deficits in emotion processing abilities, and these effects might be mediated via alterations in oxytocin production or sensitivity. The goal of this study was to test whether emotion recognition abilities and empathy might be improved by intranasal oxytocin administration in adults with a history of childhood maltreatment.

In a double-blind, placebo-controlled experiment with a crossover design, we assessed the performance of 40 healthy participants with a history of childhood adversity on the Reading the Mind in the Eyes Test (RMET) and an emotion recognition task under 24 IU oxytocin vs. placebo and compared them to a control group of 40 matched individuals without traumatic childhood experiences.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • presence of moderate to severe experiences of childhood adversity (early adversity group)

排除标准

  • Acute psychiatric disorders and personality disorders or psychiatric disorders within the last 12 months
  • Pregnancy

研究组 & 干预措施

Oxytocin

Active Comparator

Single dose of intranasally administered 24 IU of Oxytocin (Syntocinon-Spray Novartis, Switzerland)

干预措施: Oxytocin (Drug)

Placebo

Placebo Comparator

All ingredients except for oxytocin.

干预措施: Placebo (Other)

结局指标

主要结局

Reading the Mind in the Eyes Test

时间窗: 45 minutes post-dose

Requires participants to infer complex mental states fromthe eye region

Gradual Emotion Recognition Test

时间窗: 50 minutes post-dose

Requires participants to swiftly and accurately detect basic emotions form naturalistic, animated stimuli.

次要结局

未报告次要终点

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Robert Kumsta

Professor of Genetic Psychology

Ruhr University of Bochum

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