NCT00511628

Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,717 (actual)
• Sponsor: Janssen-Cilag, S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.

Detailed description

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).

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorder

Interventions

Type	Name	Description
DRUG	Risperidone	As prescribed

Timeline

• Start date: 2001-07-01
• Completion: 2003-01-01
• First posted: 2007-08-06
• Last updated: 2011-05-19