Evaluation and Validation of Social Cognition Battery to Characterize Schizophrenic Patients Functioning (EVACO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 173
- 试验地点
- 16
- 主要终点
- Change in cognitive skills
研究概览
简要总结
Interventional, multicenter, and longitudinal study, of a cohort of patients with schizophrenia, evaluated on social cognition, neurocognition, symptoms, functioning with 12 months interval.
详细描述
The main objective is evaluation and validation of social cognition battery, characterizing the psychometric properties (validity, sensitivity to change) measures in a cohort of schizophrenic patients. Other objective is to demonstrate that the various components operating at T0 and T12 months of schizophrenic patients, as an external validator, are significantly explained by social cognition performance given the third known factors : neuropsychological, sociodemographic, disease course, and clinical status. Search and model relationships between the measured variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age > 18 years and < 65 years
- •Patient's state allows cognitive and neuropsychological assessment
- •Affiliated to a social security system (beneficiary or legal).
- •Informed consent signature (patients under guardianship may be included with written permission from their legal representative).
排除标准
- •Alcohol dependence or current toxic
- •Electroconvulsivotherapy (less than 6 months)
- •Serious head trauma (become unconscious), epilepsy or neurological disorder significant or evolutionary
- •Invalidating and uncorrected visual disorder
- •Invalidating and not paired hearing
- •Actually hospitalized under constraint
- •Patient not able to come to different evaluations, or who plan to change medical care in the following year
研究组 & 干预措施
Schizophrenic patients group 1
80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).
干预措施: Assessment battery A (Behavioral)
Schizophrenic patients group 2
80 patients evaluated in the Fondamental Expertise Center for schizophrenia Network (8 centers in France).
干预措施: Assessment battery B (Behavioral)
结局指标
主要结局
Change in cognitive skills
时间窗: Day 0, Month 12
Change in the aggregates (average) of standardized performance levels : z-scores of Theory of mind (V-COMICS, V-SIR, SPEX), z-scores of empathy (QCAE), z-scores of facial affect recognition (TREF), z-scores of metacognition (V-COMICS meta), Intelligence quotient (WAIS-III), z-scores of treatment speed, z-scores of memory spans, z-scores of verbal memory, z-scores of visual memory, z-scores of attention/vigilance, z-scores of divided attention, z-scores of executive functions.
次要结局
- Change in Functioning(Day 0, Month 12)
- Change in Psychotic symptoms(Day 0, Month 12)
研究者
Eric BRUNET
Investigator coordinator
Versailles Hospital