PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders

May 18, 2011 updated by: Janssen-Cilag, S.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Drug: antipsychotic medications
as prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
All data is collected in just one visit (i.e. cross-sectional and retrospective data)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
1 visit (cross-sectional study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag, S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

November 10, 2006

First Submitted That Met QC Criteria

November 10, 2006

First Posted (Estimate)

November 14, 2006

Study Record Updates

Last Update Posted (Estimate)

May 19, 2011

Last Update Submitted That Met QC Criteria

May 18, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR010609

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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