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临床试验/NCT00759421
NCT00759421已完成3 期

An Exploratory Cognition Study Conducted as an add-on to Clinical Trial 11286, to Evaluate the Neurocognitive Effects of 12 Weeks Treatment With Sertindole and Olanzapine in Patients With Schizophrenia

H. Lundbeck A/S1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2006年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
96
试验地点
1
主要终点
Global cognitive composite score

研究概览

简要总结

The purpose of this exploratory study is to evaluate the effects of sertindole and olanzapine on neurocognitive functioning in patients with schizophrenia.

详细描述

Cognitive deficits, including impairments in areas such as memory, attention, and executive function, are major determinants and predictors of long-term disability in schizophrenia. At present, available antipsychotic medications are relatively ineffective in improving cognition. However, scientific discoveries during the past decade suggest that it may be possible to develop medications that are effective in improving cognition in schizophrenia.

One of the important reasons to focus on cognitive deficits as a target for pharmacological treatment, is the association found between cognitive impairment and social dysfunction observed in patients with schizophrenia. Pervasive cognitive deficits have a limiting effect on the quality of life of patients with schizophrenia including social interaction and problem solving, community living, and employment prospects.

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
Double (Participant, Investigator)

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

入选标准

  • Patients with schizophrenia
  • Participation in 11286 study
  • Capable of completing all study-related psychometric activities for the duration of the study

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

干预措施: Sertindole (Drug)

2

Active Comparator

干预措施: Olanzapine (Drug)

结局指标

主要结局

Global cognitive composite score

时间窗: 12 weeks

次要结局

  • Cognitive performance in the following domains: 1) Working memory; 2) Attention and vigilance; 3) Verbal learning and memory; 4) Visual learning and memory; 5) Reasoning and problem solving; 6) Speed of processing(12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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