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Study on the Safety and Effectiveness of Risperidone Treatment of Acute Psychotic Patients

Aggressiveness and Agitation of Acute Psychotic Patients: Influence in Safety and Effectiveness of Risperidone Treatment

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00515489
Enrollment
1882
Registered
2007-08-13
Start date
2001-11-30
Completion date
2002-08-31
Last updated
2011-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia, Schizophreniform Disorders

Keywords

Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders

Brief summary

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.

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).

Interventions

DRUGRisperidone

as prescribed

Sponsors

Janssen-Cilag, S.A.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

Secondary

MeasureTime frame
Effectiveness3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026