跳至主要内容
临床试验/NCT00515489
NCT00515489终止不适用

Aggressiveness and Agitation of Acute Psychotic Patients: Influence in Safety and Effectiveness of Risperidone Treatment

Janssen-Cilag, S.A.0 个研究点目标入组 1,882 人开始时间: 2001年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1,882
主要终点
Safety of risperidone treatment in acute psychotic patients that require an admission into emergency.

研究概览

简要总结

The purpose of this study was to evaluate the safety of risperidone treatment in acute psychotic patients that require an admission into emergency department. The effectiveness of risperidone in controlling acute psychotic symptomatology and incidence, severity and risk of psychomotor agitation in acute psychotic patients was also studied.

详细描述

Antipsychotic drugs are key treatment for the acute psychotic symptoms experienced by schizophrenic, schizoaffective disorder and schizophreniform disorder patients. In the last years, atypical antipsychotics having fewer side effects than conventional neuroleptics, have been introduced into clinical practice. There is not an agreement about what type of drugs should be used in an emergency situation (acute psychotic patient). The aim of this observational, prospective study was to evaluate the impact of a treatment regimen with the atypical antipsychotic drug, risperidone, as first line treatment in acute psychotic patients that requested an admission into the hospital. Effectiveness of risperidone treatment was measured by Positive and Negative Syndrome Scale (PANSS) agitation sub scale, Brief Psychotic Rating Scale and days of in-patient period. Aggressive behavior was rated using Staff Observation Aggression Scale (SOAS) and Visual Analogic Scale for agitation and anxiety. Safety was evaluated collecting elicited adverse events. Observational study - Risperidone, 3-6 mg per day, orally, during the study period (in-patient period for each patient).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Acute Psychotic symptoms in Schizophrenia
  • Schizoaffective disorder and Schizophreniform disorders in patients that required an admission into a hospital and in which physicians considered the use of risperidone as treatment under clinical practice

排除标准

  • Pregnant or lactating patients
  • Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
  • Patients with neurology pathology except Parkinsonism induced by neuroleptics
  • Patients with other severe concomitant pathology
  • Patients treated with risperidone in the last 30 days

研究组 & 干预措施

001

Risperidone as prescribed

干预措施: Risperidone (Drug)

结局指标

主要结局

Safety of risperidone treatment in acute psychotic patients that require an admission into emergency.

时间窗: 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit

次要结局

  • Effectiveness(3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit)

研究者

发起方
Janssen-Cilag, S.A.
申办方类型
Industry

相似试验

Study on the Safety and Effectiveness of Risperidone... | 临床试验