Specific Versus General Cognitive Remediation for Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 主要终点
- Change from baseline in executive functioning at week 12
研究概览
简要总结
Rationale:
Cognitive deficits are a core feature in schizophrenia. Conventional treatments (antipsychotic medication and psychological treatments) have limited effects so cognitive remediation programs were designed to alleviate the problems. Interventions typically involve a variety of exercises in a paper and pencil or a computerized format with a growing number of specialized computer programs now being developed. However, many of these programs lack specificity which does not allow an individual's specific needs to be addressed. More targeted interventions might increase the effects of therapy so RECOS - COgnitive REmediation for Schizophrenia - was developed to fit this gap.
Methods: This is a multicenter, randomized, controlled study comparing patients aged 18 to 45 years suffering from schizophrenia according to DSM-IV-TR. RECOS will be compared to an already validated program (CRT).
220 patients will be randomized as follows :
- Arm 1 : RECOS (42 h)
- Arm 2 : CRT (42 h) The recruitment is performed by psychiatrists in Lyon, Paris, Clermont-de-l'Oise, Niort, Bordeaux, Ville-Evrard and Lausanne.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women aged 18 to 45 years
- •French speaker or French schooling since 7 years
- •clinical stability
- •diagnosis of schizophrenia
排除标准
- •visual or auditory disorder
- •history of neurological illness or trauma
- •alcohol or drug dependence
- •mental retardation
结局指标
主要结局
Change from baseline in executive functioning at week 12
时间窗: week 12
BADS(Behavioral Assessement of Dysexecutive Functions) total score
次要结局
- Change from baseline in executive functioning, attention, memory and visuospatial abilities at week 12(week 12)
- Change from baseline in insight at week 12(week 12)
- Change from baseline in symptoms at week 12(week 12)
- Change from baseline in self-esteem at week 12(week 12)
研究者
Nicolas FRANCK, Pr
Professor (Claude Bernard University), head of department (Hôpital le Vinatier), principal investigator
Hôpital le Vinatier