The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Improvement in social cognition task performance
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 quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.
Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo.
Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.
Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia.
Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo.
Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 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
- •A current 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
- •Pregnancy
- •Severe brain trauma
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
Improvement in social cognition task performance
时间窗: 2-days at least 1-week apart
The outcome will be the number of tasks that improve on the oxytocin day compared to the placebo day in a panel of tasks designed to measure the subject's level of social cognition. Participants will complete social cognition tasks, which include the Auction Task, Devil's Task, Ultimatum Task, Verbal Prosody, Effort Expenditure for Rewards Task (EEfRT), and Passive Viewing Eyetracking.
次要结局
- Pre-morbid IQ Questionnaire (AmNART)(1 day)
- Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire(1 day)
- Childhood Trauma Questionnaire (CTQ)(1 day)
- Emotional Quotient Scale (EQS)(1 day)
- Kinsey Scale(1 day)
- Change in Working Memory capacity(2-days at least 1-week apart)
- Change in Auditory Perception correctness(2-days at least 1-week apart)
- Change in Auditory Perception reaction time(2-days at least 1-week apart)
研究者
Joshua Woolley
Principal Investigator
University of California, San Francisco