The Effect of Oxytocin on Fear Memory Consolidation: A Novel Intervention to Prevent PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Differential Skin Conductance Response (SCR) During the First Two Extinction Trials
研究概览
简要总结
The purpose of the study is to learn how differences in learning under mildly-stressful circumstances may be changed by taking oxytocin. Oxytocin is a hormone made naturally in the body. The investigators will also examine the impact of any anxiety, depression, and stress related symptoms on learning processes.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women 18 to 65 years of age
- •Score in study range on the Neuroticism-Extraversion-Openness-Five Factor Inventory (NEO-FFI)
- •No current Axis I Diagnostic and Statistical Manual-IV (DSM) excluded diagnoses as determined by the Structured Clinical Interview DSM (SCID) completed within the past 4 months.
- •Must be able and willing to understand study procedures and return to the clinic on two separate consecutive days for the fear-conditioning procedures.
- •Subjects must be able to give informed consent and be willing and able to comply with study procedures.
排除标准
- •Presence of a current DSM-IV Axis I diagnosis as measured by the SCID.
- •A serious medical condition or other condition deemed likely to result in surgery or hospitalization, or which would make participation in the study difficult.
- •Patients with a history of trauma resulting in head injury related seizures or with epilepsy (except a prior history of febrile seizures of infancy which are not exclusionary).
- •Use of supplemental hormones (birth control, estrogen, testosterone, prednisone, etc) or narcotics.
- •Pregnant or lactating women.
- •Women of childbearing potential not using medically accepted forms of contraception.
- •Current use of the excluded psychiatric medications.
- •Known hypersensitivity to oxytocin
- •Known hyponatremia.
研究组 & 干预措施
Placebo
Matched nasal spray placebo.
干预措施: Placebo (Drug)
Oxytocin
Liquid intranasal oxytocin administered in a nasal spray.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Differential Skin Conductance Response (SCR) During the First Two Extinction Trials
时间窗: Day 2 of Conditioning (1 day post Day 1 of Conditioning)
Differences in skin conductance response (SCR) between the active vs. placebo conditions trials will be used to assess for the impact of oxytocin on fear acquisition and extinction. We will take a mean of the first two extinction trials to get this measure. Data was gathered in micro-Siemens and then underwent a square root transformation.
次要结局
未报告次要终点
研究者
Elizabeth A. Hoge, MD
Psychiatrist
Massachusetts General Hospital