Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Change 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 and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders.
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.
详细描述
Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires. The study will be conducted with the same study arms and study interventions as in the proposed parent study. For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.
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 45 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 Social Cognition Task Performance
时间窗: Through study completion, 2-3 weeks
Participants will undergo computer tasks that measure social cognition. Tasks will involve verbal responses, pressing buttons at specific times, listening, and viewing audio-visual stimuli. Investigators will be measuring the difference in accuracy and verbal content of the responses on the oxytocin day compared to the placebo day.
次要结局
- Physiological Measurements(Through study completion, 2-3 weeks)
- Questionnaire(At baseline visit, up to 4 hours)
研究者
Joshua Woolley
Principal Investigator
University of California, San Francisco