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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01634542

Enrollment

1433

Registered

2012-07-06

Start date

2011-02-28

Completion date

2014-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Argentina, Brazil, Canada, France, Germany, Italy, Spain, United Kingdom

Outcome results