Clinical trial NCT00515489: Study on the Safety and Effectiveness of Risperidone Treatment of Acute Psychotic Patients
Official title: Aggressiveness and Agitation of Acute Psychotic Patients: Influence in Safety and Effectiveness of Risperidone Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Keywords: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2007-08-13
Enrollment: 1882
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Safety of risperidone treatment in acute psychotic patients that require an admission into emergency.
timeFrame: 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit
Secondary outcomes:
measure: Effectiveness
timeFrame: 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag, S.A.
name: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial
role: STUDY_DIRECTOR
References: