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

NCT00358852 | Completed

• 2 other identifiers: CR011989RISSCH4075
• Study Type: observational
• Target: 2,339
• Locations: 0 countries
• Sites: N/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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Mental disorder; Schizoaffective disorder; Schizophreniform disorder; Epidemiological study; Scale validation; Relapse; Short Term Hospitalization; PRE-COG; RISSCH4075

Outcome Measures

Primary Outcomes (3)

• Time to short-term relapse

  Time to early relapse of patients discharged from a short-stay psychiatric hospitalisation unit.

  Up to 12 months

• Number of readmission of patients

  Readmission in short-stay psychiatric hospital units when the schizophrenia or schizoaffective or schizophreniform disorder relapse.

  Up to 12 months

• Clinical Global Impression - Severity (CGI-S) Score

  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.

  Up to 3 years

Secondary Outcomes (7)

• Duration of disease

  Within 3 years before the study start

• Drug abuse

  Within 3 years before the study start

• Psychiatric diagnosis

  Within 3 years before the study start

• Previous stress or event

  Within 3 years before the study start

• Hospitalizations in the previous 3 years

  Within 3 years before the study start

Study Arms (1)

Patients with Schizophrenia

Other: No intervention

Interventions

No intervention OTHER

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

Patients with Schizophrenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen-Cilag, S.A.: lead

Related Links

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

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Psychotic Disorders; Recurrence

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen-Cilag S.A., Spain Clinical Trial

  Janssen-Cilag, S.A.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: August 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 19, 2014

Record last verified: 2014-03