Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399334
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2006-11-10
Brief Title:
PROFILe3 Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders
Sponsor:
Janssen-Cilag SA
Organization:
Janssen-Cilag SA
Study Overview
Official Title:
Study PROFILe3 Clinic Observations Profile of Relapse and Readmission in EmergencyAcute Settings Epidemiologic Survey in Schizophrenic Patients
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 physicians opinion on patients 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 schizoaffectiveschizophreniform 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None