Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia
The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index|
- Safety Evaluation of Risperidone in patients who are overweight and/or obese [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2001|
|Study Completion Date:||January 2003|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511628
|Study Director:||Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial||Janssen-Cilag, S.A.|