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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 2339

Participation Criteria

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, schizoaffective / schizophreniform more than 2 years of evolution and who are admitted to inpatient psychiatric units for short stay acute care setting.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Schizophrenia	Other: No intervention; This is an observational study. The data will be collected of patients suffering from schizophrenia and schizoaffective disorder / schizophreniform.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to short-term relapse	Time to early relapse of patients discharged from a short-stay psychiatric hospitalisation unit.	Up to 12 months
Number of readmission of patients	Readmission in short-stay psychiatric hospital units when the schizophrenia or schizoaffective or schizophreniform disorder relapse.	Up to 12 months
Clinical Global Impression - Severity (CGI-S) Score	The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of disease		Within 3 years before the study start
Drug abuse		Within 3 years before the study start
Psychiatric diagnosis	Patients diagnosed with Schizophrenia or Schizoaffective/schizophreniform disorder.	Within 3 years before the study start
Previous stress or event		Within 3 years before the study start
Hospitalizations in the previous 3 years		Within 3 years before the study start
Adherence to the psychiatric treatment		Within 3 years before the study start
Previous pharmacological treatment		Within 3 years before the study start

Collaborators and Investigators

• Sponsor: Janssen-Cilag, S.A.
• Investigators: Study Director: Janssen-Cilag S.A., Spain Clinical Trial, Janssen-Cilag, S.A.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: July 28, 2006
• First Submitted That Met QC Criteria: July 28, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Estimate): March 19, 2014
• Last Update Submitted That Met QC Criteria: March 18, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Schizophrenia; Scale validation; Epidemiological study; Relapse; Schizoaffective disorder; Mental disorder; Schizophreniform disorder; Short Term Hospitalization; PRE-COG; RISSCH4075
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Recurrence
• Other Study ID Numbers: CR011989; RISSCH4075 (Other Identifier: Janssen-Cilag S.A., Spain)