Effects of a Prolonged Oxytocin Treatment on Intrusions and Amygdala Reactivity in an Analogue Trauma Model
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total number of intrusions following the first trauma movie exposure.
研究概览
简要总结
Severe traumatic experiences such as falling victim to assault, torture, or rape have deleterious effects. Clinical manifestations include intrusions, avoidance behavior, and hyperarousal, which are associated, at a circuit level, with hyperfunction of the amygdala and hypofunction of prefrontal cortex (PFC) subregions. In up to 50 % of the cases, resilience is not sufficient and trauma-exposed individuals develop posttraumatic stress disorder (PTSD). Oxytocin (OXT) is a hypothalamic peptide hormone that exerts anxiolytic effects. Recent clinical trials provide preliminary evidence that post-trauma administration of OXT could be effective as a preventive intervention for PTSD in a subsample of individuals exhibiting early PTSD symptoms prior to the onset of the disorder. However, the underlying neurobiological mechanisms are unclear. Therefore, the rationale of the present project is to expose a sample of healthy participants to experimental trauma in order to explore the circuit mechanisms by which OXT influences, and interferes with, traumatic experience. Functional magnetic resonance imaging (fMRI) will be employed in order to elucidate the long-term effects of intranasal OXT on trauma-induced intrusions, amygdala and PFC responses during an emotional face matching task and resting state functional connectivity.
详细描述
Participants will be exposed to an experimental trauma (i.e. a highly aversive movie) at days 1 and 4 of the study. After the first experimental trauma and after the first functional magnetic resonance imaging (fMRI) measurement, the participants will receive intranasal OXT or placebo in three different groups (1. OXT for six days, 2. OXT for three days and then placebo for three days, 3. placebo for six days). The same fMRI tasks will be used after the first and second trauma exposure (i.e. one measurement before the treatment and one measurement after three days of treatment).
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers
- •Right-handed
排除标准
- •Current or past psychiatric disease
- •Current or past physical illness
- •Psychoactive medication
- •Hormonal contraception
- •MRI contraindication (e.g. metal in body, claustrophobia)
研究组 & 干预措施
Oxytocin (6 days)
Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure and three days after the second trauma movie exposure (24 IU per day)
干预措施: Oxytocin (Drug)
Oxytocin (3 days)
Intranasal administration, 24 international units (IU) oxytocin for three days after the first trauma movie exposure (24 IU per day) and placebo nasal spray for three days after the second trauma movie exposure
干预措施: Oxytocin (Drug)
Placebo
Placebo nasal spray for six days
干预措施: Placebo (Drug)
结局指标
主要结局
Total number of intrusions following the first trauma movie exposure.
时间窗: Three days following the first trauma movie exposure.
The participants will be asked to complete intrusion diaries at home in the evening of the days 1 to 3. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
Neural responses to emotional faces in the amygdala.
时间窗: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate amygdala responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
Neural responses to emotional faces in the prefrontal cortex.
时间窗: Neural activations will be measured with fMRI in an emotional face matching task that lasts 20 min.
Functional magnetic resonance imaging (fMRI) will be performed to measure blood-oxygen-level dependent signal in response to emotional face stimuli. The investigators specifically plan to investigate prefrontal cortex responses to emotional faces, because pilot data indicate that neural responses to emotional faces in these regions are associated with the total number of intrusions.
fMRI resting state data
时间窗: Functional data will be acquired for 6 min.
Participants will be instructed to lie still with open eyes during the resting state measurement and not think of anything in particular.
Trauma disclosure (time spend discussing the movie)
时间窗: Six days following the first trauma movie exposure.
The intrusion diaries will contain a question for how long participants discussed the trauma movie.
Total number of intrusions following the second trauma movie exposure.
时间窗: Three days following the second trauma movie exposure.
The participants will be asked to complete intrusion diaries at home in the evening of the days 4 to 6. Intrusions will be defined as involuntary recollections relating to film events that appear, apparently spontaneously, in consciousness.
次要结局
- Changes in respiration rate in response to the trauma movie(2 min baseline before the trauma movie and during 15 min of the trauma movie.)
- Salivary cortisol concentrations(Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.)
- Changes in skin conductance level in response to the trauma movie(2 min baseline before the trauma movie and during 15 min of the trauma movie.)
- Salivary oxytocin concentrations(Immediately before the trauma movie, immediately after the trauma movie and 40 min after the trauma movie.)
- Questionnaire measurement of mood (PANAS)(10 min before and 10 min after the trauma movie.)
- Changes in pupil diameter in response to the trauma movie(2 min baseline before the trauma movie and during 15 min of the trauma movie.)
研究者
Rene Hurlemann
Vice Chair of the Department of Psychiatry and Chair of the Medical Psychology Division
University Hospital, Bonn