BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1,717
- 主要终点
- Safety Evaluation of Risperidone in patients who are overweight and/or obese
研究概览
简要总结
The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.
详细描述
This is an observational, multicenter, open and prospective study. The primary objective is to evaluate safety of risperidone in patients who are overweight and/or obese. It is expected to enroll 1500 patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI (Body Mass Index) >25, or for patients that have increased their body weight >7% in the last year with the previous treatment (even with a BMI< 25), and for patients that have shown intolerance to a previous antipsychotic treatment. The study drug is risperidone, 3-6 mg per day, orally, during the study period (6 months). All data collected will be prospective and will include the following: demographic data, psychiatric history and comorbidities, concomitant treatment, body weight, treatment history , other illness related to obesity ( such as diabetes mellitus I & II, hypertension and hypercholesterolemia) and adverse events. Observational Study: Risperidone, 3-6 mg per day, orally, during the study period (6 months).
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
- •Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI >25
- •Patients have increased their body weight >7% in the last year with the previous treatment even with a BMI< 25
- •Patients that have shown intolerance to a previous antipsychotic treatment
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 Evaluation of Risperidone in patients who are overweight and/or obese
时间窗: 6 months
次要结局
- Effectiveness(6 months)
