Scale Validation Study for Prediction of Relapse and Short Term Rehospitalization in Patients With Schizophrenia

NCT ID: NCT00358852

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2339 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-09-30

Brief Summary

The purpose of this study is to establish and validate a scale/model that can be used to evaluate the duration of time and factors between short term hospital treatment and subsequent relapse periods in patients with schizoaffective/schizophreniform disorders.

Detailed Description

This is an epidemiological (study of the distribution and determinants of health-related states or events in defined population), multicenter (study conducted at multiple sites), observational (study in which patients are observed), cross-sectional (observation of all patients at one specific point in time), prospective (in which the patients are first identified and then followed forward as time passes) study. The sources of information in the study are units medical short stay psychiatric hospitalization or the acute care of the whole country, and clinical data of the patient at discharge. No intervention will be provided in this study. The general data (age range, gender, highest level of educational attainment, level of family support, substance abuse, events stressors, type of schizophrenia according to DSM-IV criteria [Diagnostic and Statistical Manual fourth], etc) of approximately 2000 schizophrenia and schizoaffective disorder / schizophreniform patients will be collected in this study. No special tests will be done during the study. The study will collect patients' data in electronic data collection workbook and model validation will be used at 6 and 12 months to confirm no relapse / hospitalization. The study observation period corresponds to the 3 years preceding the current relapse and current income (current hospitalization period) and 12 months after admission.

Conditions

Schizophrenia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with Schizophrenia

No intervention

Intervention Type: OTHER

This is an observational study. The data will be collected of patients suffering from schizophrenia and schizoaffective disorder / schizophreniform.

Interventions

No intervention

This is an observational study. The data will be collected of patients suffering from schizophrenia and schizoaffective disorder / schizophreniform.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with Schizophrenia or Schizoaffective disorder of more than 2 years evolution and who find themselves admitted in a Short-Term Psychiatric Hospitalization Unit or Acute Unit

Exclusion Criteria

• Other patients with a psychiatric pathology different to schizophrenia, schizoaffective/schizophreniform disorders
• Patients with schizophrenia or schizoaffective/schizophreniform disorders of 2 years, or less evolution
• Pregnant, lactating, or planning to become pregnant within the next 12 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag S.A., Spain Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag, S.A.

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=286&filename=CR011989_CSR.pdf

Scale Validation of Prediction of Relapse and Rehospitalization Short Term in Patients with Schizophrenia

Other Identifiers

RISSCH4075

Identifier Type: OTHER

Identifier Source: secondary_id

CR011989

Identifier Type: -

Identifier Source: org_study_id

NCT01991496

Identifier Type: -

Identifier Source: nct_alias