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临床试验/NCT00694889
NCT00694889已完成1 期

Randomized Clinical Trial of Intensive Computer-based Cognitive Remediation in Recent-onset Schizophrenia

University of California, San Francisco4 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2007年8月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
144
试验地点
4
主要终点
Cognitive Performance, as measured by a neuropsychological battery

研究概览

简要总结

The aim of this study is to investigate the efficacy of neuroscience-guided computerized cognitive training exercises on the remediation of cognitive deficits and symptoms associated with recent-onset schizophrenia and to examine the influence of subject characteristics, brain structure and function, and pharmacotherapy on the response to remediation.

详细描述

Participation in this study will last approximately 12 months and will involve individuals with recent-onset schizophrenia. All participants will undergo baseline assessments that will include an interview, written tests, blood draws, and electroencephalogram (EEG) and magnetic resonance imaging (MRI) scans. Participants will then be assigned randomly to receive treatment with either computerized neuroadaptive cognitive training or commercially available computer games. Participants will be asked to complete 60-minute sessions of their assigned treatments 5 days per week for 8 weeks. For participants receiving cognitive training, exercises will focus on improving speed and accuracy in the perception of and response to verbal and visuospatial targets. The 8 weeks of treatment will focus on targeted cognitive training (TCT). Participants assigned to practice computer games will play standard commercially available games, with no targeted response.

Participants will repeat baseline assessments after the computer training and Month 6 of follow-up. The EEG and MRI will be repeated only at post training assessment visit. There will be a blood draw at Week 2 of treatment as well. After the Month 6 assessment, participants in the control condition will be offered an opportunity to complete an additional 8 weeks of computer training with different modules.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder
  • First psychotic episode within the last 3 years
  • Good general physical health
  • Age between 12-35
  • Is fluent and proficient in the English language
  • Achieved clinical stability (e.g., outpatient status for at least 3 months before study entry; on stable doses of medication for at least 1 month before study entry
  • Minors must have parental/legal guardian consent to participate

排除标准

  • Any neurological disorder
  • History of psychoactive substance abuse in the past 6 months

结局指标

主要结局

Cognitive Performance, as measured by a neuropsychological battery

时间窗: Measured at Baseline, Week 8, and 6 Month Follow-Up

次要结局

  • Symptom profile, as measured by clinical interviews(Measured at Baseline, Week 8, and 6 Month Follow-Up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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