NCT00515489

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,882

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2001

Shorter than P25 for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2001

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2007

Completed
Last Updated

May 19, 2011

Status Verified

March 1, 2011

First QC Date

August 10, 2007

Last Update Submit

May 18, 2011

Conditions

SchizophreniaSchizoaffective DisorderSchizophreniform Disorders

Keywords

SchizophreniaSchizoaffective DisorderSchizophreniform Disorders

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Effectiveness

    3 Visits: Basal Visit (hospitalization), Visit at 3 days, Discharge Visit

Study Arms (1)

001

Risperidone as prescribed

Drug: Risperidone

Interventions

RisperidoneDRUG

as prescribed

001

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

    Janssen-Cilag, S.A.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 10, 2007

First Posted

August 13, 2007

Study Start

November 1, 2001

Study Completion

August 1, 2002

Last Updated

May 19, 2011

Record last verified: 2011-03