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

This study has been terminated.
(Due to the achievement of minimum required sample size and new changes in local regulations.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00515489
First Posted: August 13, 2007
Last Update Posted: May 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Janssen-Cilag, S.A.
  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

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag, S.A.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Effectiveness [ Time Frame: 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515489


Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
  More Information

Additional Information:
Responsible Party: Country Medical Director, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier: NCT00515489     History of Changes
Other Study ID Numbers: CR009214
First Submitted: August 10, 2007
First Posted: August 13, 2007
Last Update Posted: May 19, 2011
Last Verified: March 2011

Keywords provided by Janssen-Cilag, S.A.:
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents