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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier:
NCT00358852
First received: July 28, 2006
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Other: No intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Scale Validation of Prediction of Relapse and Rehospitalization Short Term in Patients With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag, S.A.:

Primary Outcome Measures:
  • Time to short-term relapse [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Time to early relapse of patients discharged from a short-stay psychiatric hospitalisation unit.

  • Number of readmission of patients [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Readmission in short-stay psychiatric hospital units when the schizophrenia or schizoaffective or schizophreniform disorder relapse.

  • Clinical Global Impression - Severity (CGI-S) Score [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Duration of disease [ Time Frame: Within 3 years before the study start ] [ Designated as safety issue: No ]
  • Drug abuse [ Time Frame: Within 3 years before the study start ] [ Designated as safety issue: No ]
  • Psychiatric diagnosis [ Time Frame: Within 3 years before the study start ] [ Designated as safety issue: No ]
    Patients diagnosed with Schizophrenia or Schizoaffective/schizophreniform disorder.

  • Previous stress or event [ Time Frame: Within 3 years before the study start ] [ Designated as safety issue: No ]
  • Hospitalizations in the previous 3 years [ Time Frame: Within 3 years before the study start ] [ Designated as safety issue: No ]
  • Adherence to the psychiatric treatment [ Time Frame: Within 3 years before the study start ] [ Designated as safety issue: No ]
  • Previous pharmacological treatment [ Time Frame: Within 3 years before the study start ] [ Designated as safety issue: No ]

Enrollment: 2339
Study Start Date: August 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358852

Sponsors and Collaborators
Janssen-Cilag, S.A.
Investigators
Study Director: Janssen-Cilag S.A., Spain Clinical Trial Janssen-Cilag, S.A.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen-Cilag, S.A.
ClinicalTrials.gov Identifier: NCT00358852     History of Changes
Obsolete Identifiers: NCT01991496
Other Study ID Numbers: CR011989, RISSCH4075
Study First Received: July 28, 2006
Last Updated: March 18, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Janssen-Cilag, S.A.:
Schizophrenia
Mental disorder
Schizoaffective disorder
Schizophreniform disorder
Epidemiological study
Scale validation
Relapse
Short Term Hospitalization
PRE-COG
RISSCH4075

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014