Skip to main content
Clinical Trials/NCT00399334
NCT00399334
Completed
N/A

Study PROFILe3: Clinic Observations Profile of Relapse and Readmission in Emergency/Acute Settings: Epidemiologic Survey in Schizophrenic Patients

Janssen-Cilag, S.A.0 sites1,607 target enrollmentJune 2005

Overview

Phase
N/A
Intervention
antipsychotic medications
Conditions
Schizophrenia
Sponsor
Janssen-Cilag, S.A.
Enrollment
1607
Primary Endpoint
Determine the epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The purpose of this study is to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain.

Detailed Description

Long-term treatment in schizophrenia begins in acute hospitalization. However inadequate treatment options in non-compliant patients discharged from acute inpatient settings are often leading to recidivism and frequent re-hospitalization. The objective of this epidemiologic survey is to evaluate epidemiological characteristics of relapse and readmission in acute psychiatric units. If long-term treatment in schizophrenia begins in acute hospitalization the use of the new long-acting injectable antipsychotics after an acute psychotic episode as a standard maintenance medication could prevent relapse and readmissions. This is a pharmaco-epidemiological study, which collects structured safety data and it is carried out in Spain. All data collected will be cross-sectional or retrospective and will include the following: demographic data, diagnosis, psychiatric history and co-morbidities, hospitalization record (previous 3 years), treatment record and physician's opinion on patient's treatment compliance. The primary objectives are to evaluate epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain, to determine the most important risk factors which predicts the number of hospital re-admissions and to identify the impact of the clinical profile of patients with schizophrenia, and schizoaffective/schizophreniform disorders who suffer relapses. The second objective is to describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient. as prescribed

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
December 2005
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Janssen-Cilag, S.A.

Eligibility Criteria

Inclusion Criteria

  • Patients with Schizophrenia or Schizoaffective disorder with a diagnosis over 2 years and that are hospitalized in a Short-Term Psychiatric Hospitalization Unit or Acute Unit

Exclusion Criteria

  • Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
  • Patients with Schizophrenia or Schizoaffective disorder with a diagnosis less than 2 years

Arms & Interventions

001

Intervention: antipsychotic medications

Outcomes

Primary Outcomes

Determine the epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain

Time Frame: All data is collected in just one visit (i.e. cross-sectional and retrospective data)

Secondary Outcomes

  • Describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient.(1 visit (cross-sectional study))

Similar Trials