Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2026-03-04 @ 7:32 AM
Study NCT ID:
NCT00511628
Status:
TERMINATED
Last Update Posted:
2011-05-19
First Post:
2007-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia
Sponsor:
Janssen-Cilag, S.A.
Organization:
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 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).
Study Oversight
Has Oversight DMC:
False
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?: