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

Schizophrenia Clinical Trial

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

Status Terminated

Clinical Trial Summary

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

Clinical Trial 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). ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

• NCT number: NCT00511628
• Study type: Observational
• Source: Janssen-Cilag, S.A.
• Status: Terminated
• Phase: N/A
• Start date: July 2001
• Completion date: January 2003