Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia
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Purpose
The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.
| Condition | Intervention |
|---|---|
|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
Drug: Risperidone |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index |
- Safety Evaluation of Risperidone in patients who are overweight and/or obese [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Effectiveness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 1717 |
| Study Start Date: | July 2001 |
| Study Completion Date: | January 2003 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
001
Risperidone As prescribed
|
Drug: Risperidone
As prescribed
|
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Country Medical Director, Janssen-Cilag S.A., Spain |
| ClinicalTrials.gov Identifier: | NCT00511628 History of Changes |
| Other Study ID Numbers: | CR009313 |
| Study First Received: | August 2, 2007 |
| Last Updated: | May 18, 2011 |
| Health Authority: | Spain: Spanish Drug Agency |
Keywords provided by Janssen-Cilag, S.A.:
|
Schizophrenia Risperidone Schizoaffective disorder Schizophreniform disorder Weight gain |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 23, 2013