Schizotypal Personality Disorder Risperidone
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 主要终点
- Neurophysiological indices of self-monitoring (Error Related Negativity)
研究概览
简要总结
Neurophysiological indices of self-monitoring were assessed in a group of patients with Schizotypal Personality Disorder (SPD) and a control group. Both groups were assessed after the administration of risperidone and placebo.
详细描述
The electroencephalogram (EEG) was recorder while participants (SPD participants and controls) performed a behavioral task: the Eriksen Flanker Task. The continuous EEG was segmented, corrected for artifacts and averaged. A component of the event-related brain potential known as the error-related negativity (ERN) was identified and its amplitude quantified in microvolts.
This procedure was conducted two hours after the administration of risperidone 1 mg and placebo (lactose) on two different experimental days and for each participant group (SPD patients and controls).
The amplitude of the ERN after placebo was compared between groups to test for baseline (non-drug-induced) differences between patients and controls.
The impact of risperidone on the amplitude of the ERN was compared between the two participant groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Schizotypal Personality Disorder
排除标准
- •Major Psychiatric Disorder
- •Medical condition
研究组 & 干预措施
Schizotypal Personality Disorder
Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose).
干预措施: Risperidone (Drug)
Schizotypal Personality Disorder
Schizotypal Personality Disorder (SPD) patients. They received two interventions: risperidone 1 mg and placebo (lactose).
干预措施: Placebo (Drug)
Healthy controls
Control group consisting of healthy volunteers.They received two interventions: risperidone 1 mg and placebo (lactose).
干预措施: Risperidone (Drug)
Healthy controls
Control group consisting of healthy volunteers.They received two interventions: risperidone 1 mg and placebo (lactose).
干预措施: Placebo (Drug)
结局指标
主要结局
Neurophysiological indices of self-monitoring (Error Related Negativity)
时间窗: During acute effects of pharmacological treatment (up to 2 hours)
Amplitude of the Error Related Negativity was assessed prior to and 2 hours after treatment administration
次要结局
未报告次要终点