A Non-Interventional Prospective Cohort Study of Patients With Persistent Symptoms of Schizophrenia to Describe The Course and Burden of Illness

Hoffmann-La Roche0 sites1,433 target enrollmentFebruary 2011

ConditionsSchizophrenia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Hoffmann-La Roche
Enrollment: 1433
Primary Endpoint: Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This multicenter, prospective, non-interventional study will evaluate the prevalence and characteristics of patients with persistent symptoms of schizophrenia and the course of their illness over 24 months.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

December 2014

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Diagnosis of schizophrenia according to Diagnostic and Statistical Manual for Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) or International Classification of Diseases, 10th revision (ICD-10)
•Caregivers:
•Age \>/= 18 years
•Family member or friend of the patient, who spends at least 4 hours a week with the patient

Exclusion Criteria

•Acute psychotic exacerbation in the 3 months prior to the baseline observation (e.g. hospitalization or increased psychiatric care in order to prevent hospitalization)
•Enrolled in an interventional study at the baseline observation

Outcomes

Primary Outcomes

Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores

Time Frame: from baseline to Month 24

Secondary Outcomes

Frequency/characteristics (PANSS) of patients with diagnosis of schizophrenia of >/= 12 months duration before baseline(at screening (approximately 18 months))
Medical resource utilization/costs(24 months)
Duration/severity of symptoms of schizophrenia according to Personal Social Performance Scale (PSP) / Health Related Quality of Life (HRQoL) questionnaire(24 months)