Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Social Cognition Composite Score
研究概览
简要总结
This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.
详细描述
The study will determine whether oxytocin (OT) administration 30 min before a training session enhances the learning of social information in the context of a social cognitive skills training (SCST) program, and it will test a possible mediator of this effect. Subjects with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with training control condition. Target engagement will be measured in an OT challenge (placebo versus OT one week apart) prior to baseline assessment. The measure of target engagement will be EEG mu suppression while observing biological motion. A social cognition battery will be administered at baseline, at midpoint after 6 weeks of SCST, and at completion of training at 12 weeks. The battery will include measures of social cue identification and mentalizing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-Blind Placebo controlled
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
- 否
入选标准
- •Schizophrenia or schizoaffective disorder
- •stable on an antipsychotic medication
排除标准
- •positive pregnancy test history of head injury
研究组 & 干预措施
Oxytocin with SCST
Oxytocin with SCST (active condition)
干预措施: Oxytocin nasal spray (Drug)
Oxytocin with SCST
Oxytocin with SCST (active condition)
干预措施: Social Cognition Skills Training (Behavioral)
Oxytocin with Health Management
Administration of OT with control psychosocial treatment
干预措施: Oxytocin nasal spray (Drug)
Oxytocin with Health Management
Administration of OT with control psychosocial treatment
干预措施: Health Management (Behavioral)
Placebo with SCST
Administration of Placebo with active psychosocial treatment
干预措施: Social Cognition Skills Training (Behavioral)
Placebo with SCST
Administration of Placebo with active psychosocial treatment
干预措施: Placebo nasal spray (Drug)
Placebo with HM
Administration of Placebo with control psychosocial treatment
干预措施: Health Management (Behavioral)
Placebo with HM
Administration of Placebo with control psychosocial treatment
干预措施: Placebo nasal spray (Drug)
结局指标
主要结局
Social Cognition Composite Score
时间窗: 16 weeks
We will assess social cognition in two subdomains: (1) social cue identification (Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) branch 1, Ekman, Profile of Nonverbal Sensitivity (PONS); and (2) mentalizing (The Awareness of Social Inference Test (TASIT). and Empathic accuracy) (see below). The primary summary measure for each test will be mean-centered and standardized to create a Z-score. These Z-scores will be averaged to create a single composite score for social cognition that will serve as the primary outcome measure.
次要结局
- Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery(16 weeks)
研究者
Stephen R. Marder
Professor
University of California, Los Angeles