Double-blind, Placebo-controlled, Randomized Study: Oxytocin Modulation of Startle Reactivity to Social Stimuli and Moral Decision Making
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration
研究概览
简要总结
The purpose of this study is to determine whether oxytocin affects the modulation of startle reactivity by aversive social stimuli and to investigate the oxytocin effect on moral judgements. Furthermore the investigators explore the effects of oxytocin receptor (OXTR) polymorphisms on behavioral responses to social stimuli.
详细描述
The neuropeptide oxytocin (OXT) can enhance the impact of positive social cues but may reduce that of negative ones, although it is unclear whether the latter causes blunted emotional responses. After OXT or placebo application participants are exposed to acoustic startle probes presented alone and during viewing of 60 color pictures mostly selected from the 'International Affective Picture System'. The paradigm featured 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. In the other part of the experiment, after intranasal OXT or placebo application participants respond to 60 moral dilemmas.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers
排除标准
- •Current or past psychiatric disease
- •Current or past physical illness
- •Psychoactive medication
- •Tobacco smokers
研究组 & 干预措施
Oxytocin
24 IU Oxytocin, intranasal application 45 min prior to the experiment
干预措施: Oxytocin (Drug)
Placebo
intranasal application, sodium chloride solution, 3 puffs per nostril
干预措施: Oxytocin (Drug)
结局指标
主要结局
baseline startle magnitude and affective modulation of the startle magnitude after oxytocin and placebo administration
时间窗: 24 Months
The experimental tasks started 45 min after intranasal OXT/PLC administration. The STARTLE-paradigm features 20 negative (mostly threatening), 20 neutral, and 20 positive pictures, presented for 5 s each. The startle stimulus consists of a single 50-ms burst of white noise (100 dB) with nearly instantaneous rise and was delivered binaurally via headphones during 60% of the pictures (i.e. 12 from each category) at 2 - 4 s after picture onset. We examined the baseline startle magnitude as well as the affective modulation of the startle magnitude.
次要结局
- moral decision making after oxytocin and placebo administration(24 months)
- oxytocin receptor (OXTR) polymorphism and correlation with social behavior(24 months)
研究者
Rene Hurlemann
MSc MD PhD
University Hospital, Bonn