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临床试验/NCT00063297
NCT00063297已完成2 期

Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.29 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2003年5月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
180
试验地点
29

研究概览

简要总结

This study is to determine the efficacy (how well the drug works), safety, and side effects of the study medication compared to placebo in the treatment of the negative symptoms of schizophrenia in adults.

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults aged 18-60
  • •Current diagnosis of schizophrenia
  • •Significant negative symptoms with few positive symptoms (e.g. hallucinations, delusions) and no evidence of major depression.
  • •Female subjects of childbearing potential must test negative for pregnancy at the time of enrollment.
  • •Subjects must be able to provide consent
  • •Must be healthy based on medical exam, laboratory tests and electrocardiogram

排除标准

  • •Female subjects who are either pregnant or nursing.
  • •Acute or unstable medical conditions
  • •Diseases of the central nervous system
  • •Subjects who are judged clinically to be at serious risk for suicide or violence
  • •Subjects with delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder, major depressive disorder,alcohol or drug dependence

研究者

研究点 (29)

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