Scale Validation Study for Prediction of Relapse and Short Term Rehospitalization in Patients With Schizophrenia (PRE-COG)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Schizophrenia

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00358852

CR011989

RISSCH4075 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,339 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,339 participants in 1 patient group

Patients with Schizophrenia

Treatment:

Other: No intervention