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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00515489
• Other study ID #: CR009214
• Status: Terminated
• Phase: N/A
• First received: August 10, 2007
• Last updated: May 18, 2011
• Start date: November 2001
• Est. completion date: August 2002

Study information

• Verified date: March 2011
• Source: Janssen-Cilag, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Drug Agency
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1882
• Est. completion date: August 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorders

Intervention

Drug:
• Risperidone
as prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag, S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Effectiveness		3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit	No

External Links

•   Impact of aggressiveness/agitation in response and safety to risperidone in acute psychotic patients.