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临床试验/NCT00511628
NCT00511628终止不适用

BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index

Janssen-Cilag, S.A.0 个研究点目标入组 1,717 人开始时间: 2001年7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
1,717
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

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)

研究者

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

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