NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia

The purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline and the last study visit. The secondary study objectives are to compare general functioning of patients with schizophrenia treated with other atypical antipsychotic medicinal products administered once daily between baseline and the last study visit, monitoring of other indicators of clinical improvement, evaluation of patient compliance and assessment of occurrence of adverse effects

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Begunje na Gorenjskem, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
patients' symptoms are controlled with Seroquel SR started up to 1 month before the inclusion
or patients' symptoms are controlled with other atypical antipsychotic in once daily formulation started up to 1 month before the inclusion

Exclusion criteria

patients who are treated with Seroquel SR or other antipsychotic more than 1 month
patients with prescribed antipsychotic combinations
pregnant women or women who are breast-feeding
patients who have been treated with antipsychotics in depot formulations for the last two months

Treatment and study plan

Primary outcomes

To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group.

Time frame: three times: 0, 12 and 24 weeks after inclusion

Secondary outcomes

To assess improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the group of patients treated with other atypical antipsychotics

Time frame: three times: 0, 12 and 24 weeks after inclusion

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Feb 2, 2009
Registry last updated: Oct 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed