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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00358852
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : March 19, 2014
Information provided by (Responsible Party):
Janssen-Cilag, S.A.

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.

Condition or disease Intervention/treatment
Schizophrenia 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.

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Study Type : Observational
Actual Enrollment : 2339 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Scale Validation of Prediction of Relapse and Rehospitalization Short Term in Patients With Schizophrenia
Study Start Date : August 2006
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.

Primary Outcome Measures :
  1. Time to short-term relapse [ Time Frame: Up to 12 months ]
    Time to early relapse of patients discharged from a short-stay psychiatric hospitalisation unit.

  2. Number of readmission of patients [ Time Frame: Up to 12 months ]
    Readmission in short-stay psychiatric hospital units when the schizophrenia or schizoaffective or schizophreniform disorder relapse.

  3. Clinical Global Impression - Severity (CGI-S) Score [ Time Frame: Up to 3 years ]
    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 :
  1. Duration of disease [ Time Frame: Within 3 years before the study start ]
  2. Drug abuse [ Time Frame: Within 3 years before the study start ]
  3. Psychiatric diagnosis [ Time Frame: Within 3 years before the study start ]
    Patients diagnosed with Schizophrenia or Schizoaffective/schizophreniform disorder.

  4. Previous stress or event [ Time Frame: Within 3 years before the study start ]
  5. Hospitalizations in the previous 3 years [ Time Frame: Within 3 years before the study start ]
  6. Adherence to the psychiatric treatment [ Time Frame: Within 3 years before the study start ]
  7. Previous pharmacological treatment [ Time Frame: Within 3 years before the study start ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00358852

Sponsors and Collaborators
Janssen-Cilag, S.A.
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Study Director: Janssen-Cilag S.A., Spain Clinical Trial Janssen-Cilag, S.A.
Additional Information:
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Responsible Party: Janssen-Cilag, S.A. Identifier: NCT00358852    
Obsolete Identifiers: NCT01991496
Other Study ID Numbers: CR011989
RISSCH4075 ( Other Identifier: Janssen-Cilag S.A., Spain )
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014
Keywords provided by Janssen-Cilag, S.A.:
Mental disorder
Schizoaffective disorder
Schizophreniform disorder
Epidemiological study
Scale validation
Short Term Hospitalization
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Disease Attributes
Pathologic Processes