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