Clinical trial NCT00358852: Scale Validation Study for Prediction of Relapse and Short Term Rehospitalization in Patients With Schizophrenia
Official title: Scale Validation of Prediction of Relapse and Rehospitalization Short Term in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Mental disorder
Schizoaffective disorder
Schizophreniform disorder
Epidemiological study
Scale validation
Relapse
Short Term Hospitalization
PRE-COG
RISSCH4075
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2006-08-01
Enrollment: 2339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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 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

Primary outcomes:
measure: Time to short-term relapse
timeFrame: Up to 12 months
measure: Number of readmission of patients
timeFrame: Up to 12 months
measure: Clinical Global Impression - Severity (CGI-S) Score
timeFrame: Up to 3 years
Secondary outcomes:
measure: Duration of disease
timeFrame: Within 3 years before the study start
measure: Drug abuse
timeFrame: Within 3 years before the study start
measure: Psychiatric diagnosis
timeFrame: Within 3 years before the study start
measure: Previous stress or event
timeFrame: Within 3 years before the study start
measure: Hospitalizations in the previous 3 years
timeFrame: Within 3 years before the study start
measure: Adherence to the psychiatric treatment
timeFrame: Within 3 years before the study start
measure: Previous pharmacological treatment
timeFrame: Within 3 years before the study start
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag, S.A.
name: Janssen-Cilag S.A., Spain Clinical Trial
role: STUDY_DIRECTOR
References: