PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00399334
• Other study ID #: CR010609
• Status: Completed
• Phase: N/A
• First received: November 10, 2006
• Last updated: May 18, 2011
• Start date: June 2005
• Est. completion date: December 2005

Study information

• Verified date: April 2010
• Source: Janssen-Cilag, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Drug Agency
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1607
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

Drug:
• antipsychotic medications
as prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag, S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient.		1 visit (cross-sectional study)	No

External Links

•   Epidemiological study to analyze the clinical profile of patients with schizophrenia in short-stay psychiatric hospitalization units