- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00515489
Study on the Safety and Effectiveness of Risperidone Treatment of Acute Psychotic Patients
May 18, 2011 updated by: Janssen-Cilag, S.A.
Aggressiveness and Agitation of Acute Psychotic Patients: Influence in Safety and Effectiveness of Risperidone Treatment
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.
Study Overview
Status
Terminated
Intervention / Treatment
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).
Study Type
Observational
Enrollment (Actual)
1882
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
001
Risperidone as prescribed
|
as prescribed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effectiveness
Time Frame: 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit
|
3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2001
Study Completion (Actual)
August 1, 2002
Study Registration Dates
First Submitted
August 10, 2007
First Submitted That Met QC Criteria
August 10, 2007
First Posted (Estimate)
August 13, 2007
Study Record Updates
Last Update Posted (Estimate)
May 19, 2011
Last Update Submitted That Met QC Criteria
May 18, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Disease
- Psychotic Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- Risperidone
Other Study ID Numbers
- CR009214
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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