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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:
Information provided by:
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT00515489
First received: August 10, 2007
Last updated: May 18, 2011
Last verified: March 2011
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness [ Time Frame: 3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Country Medical Director, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier: NCT00515489     History of Changes
Other Study ID Numbers: CR009214
Study First Received: August 10, 2007
Last Updated: May 18, 2011
Health Authority: Spain: Spanish Drug Agency

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

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

ClinicalTrials.gov processed this record on November 25, 2014