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

This study is ongoing, but not recruiting participants.

Sponsored by: Janssen-Cilag S.A., (formerly Janssen Sp)
Information provided by: Janssen-Cilag S.A., (formerly Janssen Sp)
ClinicalTrials.gov Identifier: NCT00511628
  Purpose

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


Condition Phase
Schizophreniform Disorder
Schizoaffective Disorder
Schizophrenia
Phase IV

MedlinePlus related topics:   Obesity    Psychotic Disorders    Schizophrenia   

ChemIDplus related topics:   Risperidone   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:   BMI-2002 Study. Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index.

Further study details as provided by Janssen-Cilag S.A., (formerly Janssen Sp):

Estimated Enrollment:   1500
Estimated Study Completion Date:   November 2002

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's 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; patients have increased their body weight >7% in the last year with the previous treatment even with a BMI< 25; and 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.

Risperidone, 3-6 mg per day, orally, during the study period (6 months).

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI >25
  • Patients have increased their body weight >7% in the last year with the previous treatment even with a BMI< 25 - Patients that have shown intolerance to a previous antipsychotic treatment

Exclusion Criteria:

  • Pregnant or lactating patients
  • Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
  • Patients with neurology pathology except Parkinsonism induced by neuroleptics
  • Patients with other severe concomitant pathology
  • Patients treated with Risperidone in the last 30 days
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511628

Sponsors and Collaborators
Janssen-Cilag S.A., (formerly Janssen Sp)

Investigators
Study Director:     Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial     Janssen-Cilag S.A., (formerly Janssen Sp)    
  More Information


Study ID Numbers:   CR009313
First Received:   August 2, 2007
Last Updated:   August 2, 2007
ClinicalTrials.gov Identifier:   NCT00511628
Health Authority:   Spain: Spanish Drug Agency

Keywords provided by Janssen-Cilag S.A., (formerly Janssen Sp):
Risperidone  
weight gain  
Schizophreniform disorder  
Schizophrenia  
Schizoaffective disorder  

Study placed in the following topic categories:
Schizophrenia
Body Weight
Obesity
Mental Disorders
Risperidone
Psychotic Disorders
Overweight
Weight Gain
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 17, 2008




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