Study on the Safety and Effectiveness of Risperidone Treatment of Acute Psychotic Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorders |
Drug: Risperidone |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Aggressiveness and Agitation of Acute Psychotic Patients: Influence in Safety and Effectiveness of Risperidone Treatment |
- Safety of risperidone treatment in acute psychotic patients that require an admission into emergency. [ Time Frame: 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit ] [ Designated as safety issue: No ]
- Effectiveness [ Time Frame: 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit ] [ Designated as safety issue: No ]
| Enrollment: | 1882 |
| Study Start Date: | November 2001 |
| Study Completion Date: | August 2002 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
001
Risperidone as prescribed
|
Drug: Risperidone
as prescribed
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Inclusion Criteria:
- 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
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: | NCT00515489 History of Changes |
| Other Study ID Numbers: | CR009214 |
| Study First Received: | August 10, 2007 |
| Last Updated: | May 18, 2011 |
| Health Authority: | Spain: Spanish Drug Agency |
Keywords provided by Janssen-Cilag, S.A.:
|
Schizophrenia Schizoaffective Disorder Schizophreniform Disorders |
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 16, 2013