NCT00563017Unknown不适用
Evaluation of Efficacy and Safety of Long-acting Risperidone Microspheres in Patients With Schizophrenia or Other Psychotic Disorders When Switching From Typical Antipsychotic (Oral/Depot) or Atypical Oral Other Than Risperidone
Hospital Authority, Hong Kong1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Personal and Social Performance Scale
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, tolerability and safety of patients on long-acting Risperidone microshpheres injection. The major advantage of long-acting injection over oral medication is facilitation of compliance in medication taking. Non-compliance is very common among schizophrenic and is a frequent cause of relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with schizophrenia or another psychotic disorder according to DSM IV criteria who requires long term antipsychotic therapy
- •Currently treated with either an atypical antipsychotic, other than risperidone, a conventional depot antipsychotic or oral conventional antipsychotic
- •Subject has been symptomatically stable on a stable dose of an antipsychotic the last month
- •Subject and/or patient's relative, guardian or legal representative has signed the informed consent form
排除标准
- •First antipsychotic treatment ever
- •On clozapine during the last 3 month
- •Serious unstable medical condition
- •History or current symptoms of tardive dyskinesia
- •History of neuroleptic malignant syndrome
- •Pregnant or breast-feeding female
- •Female patient of childbearing potential without adequate contraception.
- •Participation in an investigational drug trial in the 30 days prior to selection
- •Known intolerance/non-responder to risperidone
结局指标
主要结局
Personal and Social Performance Scale
时间窗: Week 0, 12
Efficacy/ Clinical Global Impression
时间窗: Week 0, 4, 8,12
Extrapyramidal Symptom
时间窗: Week 0, 4, 8,12
次要结局
- Pain assoicated with injection VAS(Week 0, 4, 8, 12)
- +Quality of life SF-36(Week 0,12)
研究者
研究点 (1)
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