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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 was to evaluate the safety of risperidone treatment in acute psychotic patients that require an admission into emergency department. The effectiveness of risperidone in controlling acute psychotic symptomatology and incidence, severity and risk of psychomotor agitation in acute psychotic patients was also studied.
Antipsychotic drugs are key treatment for the acute psychotic symptoms experienced by schizophrenic, schizoaffective disorder and schizophreniform disorder patients. In the last years, atypical antipsychotics having fewer side effects than conventional neuroleptics, have been introduced into clinical practice. There is not an agreement about what type of drugs should be used in an emergency situation (acute psychotic patient). The aim of this observational, prospective study was to evaluate the impact of a treatment regimen with the atypical antipsychotic drug, risperidone, as first line treatment in acute psychotic patients that requested an admission into the hospital. Effectiveness of risperidone treatment was measured by Positive and Negative Syndrome Scale (PANSS) agitation sub scale, Brief Psychotic Rating Scale and days of in-patient period. Aggressive behavior was rated using Staff Observation Aggression Scale (SOAS) and Visual Analogic Scale for agitation and anxiety. Safety was evaluated collecting elicited adverse events. Observational study - Risperidone, 3-6 mg per day, orally, during the study period (in-patient period for each patient).
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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 of risperidone treatment in acute psychotic patients that require an admission into emergency. | 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit |
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Inclusion Criteria:
Exclusion Criteria:
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Acute Psychotic symptoms in Schizophrenia; Schizoaffective disorder and Schizophreniform disorders in patients that required an admission into a hospital and in which physicians considered the use of risperidone as treatment under clinical practice
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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 |
|---|---|
| Impact of aggressiveness/agitation in response and safety to risperidone in acute psychotic patients. | View source |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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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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