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Completed

NCT Number: NCT00358852

Scale Validation Study for Prediction of Relapse and Short Term Rehospitalization 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Janssen-Cilag, S.A.

Industry

Registry information

Official study title

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

Acronym: PRE-COG

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 1, 2006
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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