PRE-COG Validation to Predict the Risk of Hospitalization of Discharged Patients With Schizophrenia in the Short Term.
The purpose of this study is to establish and validate a scale/model that can be used in the evaluation of the duration of time and factors between short term hospital treatment and subsequent relapse periods in patients with schizoaffective/schizophreniform disorders.
|Official Title:||Scale Validation of the Prediction of Relapses and Short-Term re-Hospitalization of Patients With Schizophrenia.|
|Study Start Date:||July 2006|
|Study Completion Date:||September 2008|
This is an epidemiological, multicentre, observational, cross-sectional prospective study. This study is carried out in Spain. The primary objectives are to establish and validate a scale/model which predicts, depending on the risk factors, the short-term period of time before relapse of a patient given hospital discharge in a Short-Term Psychiatric Hospitalization Unit or Acute Unit, in Spain, to confirm the determination of the most important factors regarding number of hospital re-admissions and to recognize and assess the repercussion of the clinical profile of patients with schizophrenia, and schizoaffective/schizophreniform disorders who suffer relapses (predictive model in a cross-sectional, prospective evaluation). This study is observational and non-product specific. The illness or disorder under study is schizophrenia and schizoaffective/shizophreniform disorder according to DSM-IV criteria. The population under study is the following: patients attended to in Short-Term Psychiatric Hospitalization Units or Acute Units. Approximately 2,000 patients are estimated (see sample size calculation). The objectives require the collection of data referring to all patients seen and discharged for three consecutive months, during the second quarter of 2006, in order to achieve the desired sample size. It is therefore necessary to incorporate so many Short-Term Psychiatric Hospitalization Units or Acute Units in the project, as well as to include 300 consultant psychiatric investigators in practice at the time of data collection and who are able to assist with recruitment. This study will be performed under normal conditions of medical conduct and in accordance with clinical practice. It will consist of the collection of background data (age intervals, sex, maximum level of education achieved, degree of family support, substance consumption, stressful events, type of schizophrenia according to DSM-IV, etc). No extra tests will be performed during the study, nor whilst completing the electronic Case Report Form (e-CRF). All AE and all SAE will be recorded on the e-CRF. This data will be kept at the centre until it is sent to Janssen-Cilag. Janssen-Cilag will prepare a final report of the study including all AE and SAE. All SAE occurring with the administration of Janssen-Cilag drugs must be reported by the doctor within 24 hour of their knowledge to the person responsible for pharmacovigilance designed by Janssen-Cilag Spain using the Serious Adverse Event Report Form. Pregnancies are treated as if they were SAEs during the study. All pregnancies occurring with the administration of Janssen-Cilag drugs must be reported by the doctor within 24 hour of their knowledge to the person responsible for pharmacovigilance designed by Janssen-Cilag Spain using the Pregnancy Report Form.