PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders

This study has been completed.
Sponsor:
Information provided by:
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT00399334
First received: November 10, 2006
Last updated: May 18, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Drug: antipsychotic medications

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Study PROFILe3: Clinic Observations Profile of Relapse and Readmission in Emergency/Acute Settings: Epidemiologic Survey in Schizophrenic Patients

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag, S.A.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe the clinical decisions made by psychiatrist regarding therapeutic approach according to the previous characteristics of the patient. [ Time Frame: 1 visit (cross-sectional study) ] [ Designated as safety issue: No ]

Enrollment: 1607
Study Start Date: June 2005
Study Completion Date: December 2005
Groups/Cohorts Assigned Interventions
001 Drug: antipsychotic medications
as prescribed

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399334

Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial Janssen-Cilag, S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: Country Medical Director, Janssen-Cilag S.A., Spain
ClinicalTrials.gov Identifier: NCT00399334     History of Changes
Other Study ID Numbers: CR010609
Study First Received: November 10, 2006
Last Updated: May 18, 2011
Health Authority: Spain: Spanish Drug Agency

Keywords provided by Janssen-Cilag, S.A.:
Schizophrenia
Schizoaffective
relapse
risk factors
Observational study
Antipsychotic medication

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 16, 2014