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Due to the achievement of minimum required sample size and new changes in local regulations.
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The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Risperidone As prescribed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | As prescribed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Evaluation of Risperidone in patients who are overweight and/or obese | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial | Janssen-Cilag, S.A. | Study Director |
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| Label | URL |
|---|---|
| Study on the safety of risperidone on obese or overweight patients with schizophrenia. | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |