Aripiprazole for Pre-Existing Neuroleptic-Induced Tardive Dyskinesia: a Prospective 26-Week Observational Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Total scores of AIMS
研究概览
简要总结
The aim of the present study was to investigate the efficacy of aripiprazole in management of pre-existing neuroleptic-induced tardive dyskinesia
详细描述
Objective
A few case reports on the use of aripiprazole in neuroleptic-induced tardive dyskinesia have demonstrated positive effects. However its effectiveness in treatment of TD was still inconclusive. The aim of the present study was to investigate the efficacy of aripiprazole in management of pre-existing neuroleptic-induced tardive dyskinesia.
Method: Subjects with pre-existing neuroleptic-induced tardive dyskinesia were chosen from Taoyuan psychiatric center. Patients recruited would be treated with aripiprazole for cross-titration with previous antipsychotics in 8 weeks. We use AIMS, SAS, & BAS to assess the severity of TF and EPS. We record subjects' age, sex, and other factors which have influence at the treatment response. Subjects are assessed every two weeks in the first month and then monthly until six months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female patients must agree to prevent from being pregnant during trial periods
- •Meet psychotic disorder or mood disorder criteria of DSM-IV
- •Patients must have psychiatric diseases that need to use antipsychotics for a long time
- •They must meet DSM-IV research criteria for neuroleptics induce tardive dyskinesia
- •No clinical significant major systemic diseases
- •No special neurological diseases which would influence the assessment for EPS or TD
- •Mentality is better than mild mental retardation
- •Patients or .legal representatives agree to join in the research and sign informed consent.
排除标准
- •Unstable major systemic diseases
- •Had neurological disorder influenced to EPS assessment
- •Substance abuse or dependence other then coffee or tobacco within 6 months before study
结局指标
主要结局
Total scores of AIMS
时间窗: The change from baseline to study endpoint
次要结局
- Total scores of PANSS(The change from baseline to study endpoint)
- Total scores of SAS(The change from baseline to study endpoint)