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临床试验/NCT00223418
NCT00223418已完成不适用

Do Patients Taking Aripiprazole Learn More in Vocational Skills Training Than Patients Taking Olanzapine?

The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2004年1月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
2
主要终点
Toilet Tank Assembly Task at 13 and 14 weeks

研究概览

简要总结

STUDY PURPOSE: To study whether patients who have schizophrenia or schizoaffective disorder and are randomly assigned to switch to aripiprazole prior to participation in a brief vocational skills training (VST) will have improved cognitive functioning and learn more in VST than those randomly assigned to stay on olanzapine. There is evidence that VST is important in improving role functioning for schizophrenia patients, however, cognitive impairments limit the ability of some patients to benefit from skills training approaches. Patients switched from olanzapine to aripiprazole improve in terms of verbal learning and verbal learning has been shown to be a strong predictor of community outcome. It is unclear whether the cognitive benefits of switching to aripiprazole extend to improve learning of vocational skills.

详细描述

Many schizophrenia outpatients have cognitive deficits and poor vocational functioning. There is evidence from randomized controlled trials that vocational skills training is important in improving vocational role functioning for schizophrenia patients. However, it has become clear that cognitive impairments limit the ability of patients to benefit from skills training approaches. Recent research demonstrates that patients switched from olanzapine to aripiprazole improve in terms of verbal learning. Verbal learning has been found to be a strong predictor of multiple domains of community outcome. It is unclear whether the cognitive benefits of switching to aripiprazole extend to improve learning of vocational skills. This study examines whether aripiprazole can improve the ability to benefit from expensive rehabilitation programs focused on skill-building. Specifically, the study examines whether patients who switch from olanzapine to aripiprazole learn more and benefit more from a brief vocational skills program than patients who remain on olanzapine. Specific aims are as follows: (1) we hypothesize that patients on aripiprazole will demonstrate better scores on tests of cognitive functioning following twelve weeks of medication treatment than patients on olanzapine and (2) we hypothesize that patients on aripiprazole will have significantly higher scores on vocational performance following a brief (2-day) vocational training and assessment session than those on olanzapine. Furthermore, we hypothesize that these gains will be maintained following one week of non-exposure to the trained vocational tasks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 52 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-IV diagnosis of schizophrenia or schizoaffective disorder
  • Between ages of 18 and 52
  • On olanzapine for a minimum of 3 months prior to participation
  • Outpatient status for at least 3 months
  • Vision and hearing intact or corrected to extent that will allow participation in vocational training and cognitive testing
  • Score in impaired range on at least one test from a cognitive battery designed to be sensitive to impairments in schizophrenia
  • Ability to participate in the informed consent process, as evidenced by an assessment of the capacity to give consent for research developed by the Maryland Psychiatric Research Center (DeRenzo et al., 1998).

排除标准

  • History of head injury, mental retardation or neurological disorder
  • Below a 4th grade reading level (32) according to the WRAT-3
  • Taking multiple atypical antipsychotics
  • Taking any decanoate antipsychotic
  • Hospitalization in last 3 months
  • Employment
  • Alcohol or drug abuse that interferes with functioning or medication compliance

结局指标

主要结局

Toilet Tank Assembly Task at 13 and 14 weeks

Card Sorting Task at baseline, 13 and 14 weeks

次要结局

  • Brief Psychiatric Rating Scale at baseline and 13 week
  • Negative Symptom Assessment at baseline and 13 week
  • Global Assessment of Functioning Scale at baseline and 13 week
  • Social and Occupational Functioning Scale at baseline and 13 week
  • Work portion of Test of Adaptive Behaviors in Schizophrenia at baseline and 13 week
  • STAN neurocognitive tests at baseline and 13 week
  • Trails A at baseline and 13 week
  • Trails Aa at baseline and 13 week
  • Trails B at baseline and 13 week

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dawn Velligan

Principal Investigator

The University of Texas Health Science Center at San Antonio

研究点 (2)

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