PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
• Interventions: Drug: antipsychotic medications

• Registration Number: NCT00399334
• Lead Sponsor: Janssen-Cilag, S.A.

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

Study Timeline

• Study Start: 2005-06
• Study Completion: 2005-12
• Study First Submitted: 2006-11-10
• Study First Submitted QC: 2006-11-10
• Study First Posted: 2006-11-14
• Status Verified: 2010-04
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1607

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
001	antipsychotic medications	-

Primary Outcome Measures

Name	Time	Method
Determine the epidemiological characteristics of patients that experience relapse and need an admission in psychiatric acute units across Spain	All data is collected in just one visit (i.e. cross-sectional and retrospective data)

Secondary Outcome Measures

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