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Sponsored by: |
Janssen-Cilag S.A., (formerly Janssen Sp) |
Information provided by: | Janssen-Cilag S.A., (formerly Janssen Sp) |
ClinicalTrials.gov Identifier: | NCT00511628 |
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 |
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. |
Estimated Enrollment: | 1500 |
Estimated Study Completion Date: | November 2002 |
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).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR009313 |
First Received: | August 2, 2007 |
Last Updated: | August 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00511628 |
Health Authority: | Spain: Spanish Drug Agency |
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