Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in MEG neural activation patterns
研究概览
简要总结
The specific aim of this proposal is to investigate the neurophysiological mechanisms of oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using magnetoencephalography.
Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will be normalized.
Hypothesis B: When OT is administered to patients with schizophrenia, the decreased functional connectivity (FC) between the amygdala, FG, and ACC will be normalized.
By elucidating the neurophysiological mechanisms of OT administration on emotional face processing, investigators will bee able to:
- understand the pathophysiology of the functionally debilitating social cognitive deficits of schizophrenia,
- test the efficacy of OT in normalizing the neural abnormalities underlying these social deficits, and
- develop and optimize novel treatments for these currently untreatable deficits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
- •DSM-IV diagnosis of any disorder other than schizophrenia
- •Medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial surgical procedures (hypophysectomy), congestion or sinus problems that could interfere with the study as per the opinion of the investigator
- •Hearing deficits
- •A pacemaker, extensive dental work, or any magnetic metal implants
- •Any history of severe brain trauma
研究组 & 干预措施
Interventional
40 IU Oxytocin
干预措施: Oxytocin (Drug)
Saline Nasal Spray
Placebo Comparator
干预措施: Saline Nasal Spray (Drug)
结局指标
主要结局
Change in MEG neural activation patterns
时间窗: Oxytocin and placebo administration days at least 1-week apart
During tasks in which participants will see and hear various stimuli, investigators will measure the change in neural activity in the amygdala, the dorsal anterior cingulate cortex, as well as the fusiform gyrus using the MEG scanner.
次要结局
- Change in performance on Facial Recognition Task(Oxytocin and placebo administration days at least 1-week apart)
- Change in performance on International Affective Picture System (IAPS) task(Oxytocin and placebo administration days at least 1-week apart)
- UCLA Loneliness Scale(1 day)
- Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire(1 day)
- Childhood Trauma Questionnaire (CTQ)(1 day)
- Parental Bonding Instrument (PBI)(1 day)
- Emotional Quotient Scale (EQS)(1 day)
- Fagerstom Nicotine Dependence Test(1 day)
- Quality of Life Scale (QLS)(1 day)
- Social Functioning Scale (SFS)(1 day)
研究者
Joshua Woolley
Principal Investigator
University of California, San Francisco