ACTRN12605000656639招募中3 期
A Naturalistic, effectiveness and efficacy study of Amisulpride in the treatment of Schizophrenia and Schizoaffective disorder
Dr. Suresh Sundram0 个研究点目标入组 40 人开始时间: 2005年10月18日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1.DSM-IV-TR Diagnosis of schizophrenia (any sub-type) or schizoaffective disorder, confirmed by the M.I.N.I. 2.Subject has read and understood the Plain Language Statement and signed the approved Informed Consent Form. 3.Subject is considered suitable by the Investigator to be treated with amisulpride (eg. Subjects requiring a switch to amisulpride due to poor efficacy and/or tolerability with a pre-study therapeutic antipsychotic medication, based on the clinical judgment of the investigator; subjects recently diagnosed with schizophrenia (any sub-type) or schizoaffective disorder; subjects currently taking amisulpride as the main therapeutic antipsychotic). 4.Subjects currently taking amisulpride as the main therapeutic antipsychotic medication.
排除标准
- •1.A current DSM-IV-TR diagnosis other than Schizophrenia (any sub-type) or Schizoaffective disorder. 2.Known hypersensitivity to amisulpride3.History of severe drug allergy or hypersensitivity4.Subjects known to be unresponsive to amisulpride5.History of Neuroleptic Malignant syndrome6.Have a clinically significant ECG abnormality that, in the opinion of the Investigator, may be adversely affected by the medication under study.7.Subjects on depot medication who have not reached one treatment cycle at the baseline point 8.Subjects taking clozapine as the previous antipsychotic, for treatment-resistant psychosis, which intended to treat their schizophrenia or schizoaffective disorder prior to entry into the project.9.Subjects who do not require a switch to amisulpride due to poor efficacy and/or tolerability with a pre-study therapeutic antipsychotic medication, based on the clinical judgment of the investigator.
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