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

• ClinicalTrials.gov Identifier: NCT00358852
• Recruitment Status: Completed
• First Posted: August 1, 2006
• Last Update Posted: March 19, 2014
• Sponsor: Janssen-Cilag, S.A.
• Information provided by (Responsible Party): Janssen-Cilag, S.A.

Study Description

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.

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

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

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:

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

• Responsible Party: Janssen-Cilag, S.A.
• ClinicalTrials.gov Identifier: NCT00358852
• Obsolete Identifiers: NCT01991496
• Other Study ID Numbers: CR011989; RISSCH4075 ( Other Identifier: Janssen-Cilag S.A., Spain )
• First Posted: August 1, 2006
• Last Update Posted: March 19, 2014
• Last Verified: March 2014

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:

Recurrence; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Disease Attributes; Pathologic Processes