PROFILe3: Epidemiologic Survey in Patients With Schizophrenia or Schizoaffective Disorders

NCT ID: NCT00399334

Last Updated: 2011-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1607 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Study Completion Date

2005-12-31

Brief Summary

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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

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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

Conditions

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Schizophrenia Schizoaffective Disorder Schizophreniform Disorder

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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001

antipsychotic medications

Intervention Type DRUG

as prescribed

Interventions

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antipsychotic medications

as prescribed

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Janssen-Cilag S.A., Spain

Principal Investigators

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Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag, S.A.

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=285&filename=CR010609_CSR.pdf

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

Other Identifiers

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CR010609

Identifier Type: -

Identifier Source: org_study_id

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