Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511628
Status:
TERMINATED
Last Update Posted:
2011-05-19
First Post:
2007-08-02
Brief Title:
Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia
Sponsor:
Janssen-Cilag SA
Organization:
Janssen-Cilag SA
Study Overview
Official Title:
BMI-2002 Study Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index
Status:
TERMINATED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the achievement of minimum required sample size and new changes in local regulations
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight andor 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None