Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - fMRI
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Change in fMRI neural activation patterns
研究概览
简要总结
In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia.
Aim 1: To examine the effects of exogenous oxytocin on patterns of neural activation as measured by fMRI during a well-characterized affect-labeling task in patients with recent-onset schizophrenia and healthy comparison subjects.
Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when passively viewing faces, which will be normalized by administration of oxytocin.
Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling faces and this hypo-activity will be normalized by oxytocin administration.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oxytocin
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 fMRI neural activation patterns
时间窗: 2-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 medial prefrontal cortex and the temporoparietal junction between placebo and oxytocin testing days using the fMRI 3T Siemens Skyra scanner.
次要结局
- Parental Bonding Instrument (PBI)(1 day)
- Social Functioning Scale (SFS)(1 day)
- Premorbid IQ test (AmNART)(1 day)
- UCLA Loneliness Scale(1 day)
- Experiences in Close Relationships - Relationship Structures (ECR-RS)(1 day)
- Socioeconomic Status (SES)(1 day)
- Emotional Quotient Scale (EQS)(1 day)
- Quality of Life Scale (QLS)(1 day)
- Kinsey Scale(1 day)
- Childhood Trauma Questionnaire (CTQ)(1 day)
研究者
Joshua Woolley
Principal Investigator
University of California, San Francisco