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临床试验/NCT00215579
NCT00215579已完成4 期

Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence

Duke University2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2004年4月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
64
试验地点
2

研究概览

简要总结

As many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly respond to these problems by adding adjunctive medications, despite the absence of systematic studies that support such practices. It is possible, however, that in many of these cases, the unstable course and/or unsatisfactory treatment response reflects incomplete adherence with the originally prescribed oral antipsychotic, rather than a need for adjunctive medications. This study will examine whether switching patients who demonstrate an unstable course and/or an unsatisfactory clinical response to a long-acting injectable preparation as the primary antipsychotic may enhance medication adherence and improve outcomes.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
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

入选标准

  • Eligible patients will be male or female
  • Between 18-65 years of age and will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
  • The subject must have, in their physicians opinion, an unstable course and must have been treated with an oral antipsychotic.

排除标准

  • Pregnant and breast feeding females will be excluded.
  • Because fluoxetine is known to change the plasma level of CONSTA, subjects taking fluoxetine within two weeks of starting the study will be excluded.
  • Patients who are known to have a hypersensitivity to oral Risperdal will be excluded.

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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