An Non-Interventional Study of Patients With Persistent Symptoms of Schizophrenia

Completed

• Conditions: Schizophrenia

• Registration Number: NCT01634542
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-07-03
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1433

Inclusion Criteria

Patients:

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Course of illness: Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores	from baseline to Month 24

Secondary Outcome Measures

Name	Time	Method
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