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

Study Overview
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Brief Summary
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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

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

Conditions
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Schizophrenia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Seroquel SR: Patients whose symptoms are controlled with Seroquel SR and started with the therapy up to 1 month before the inclusion | |
| 2<br>Atypical antipsychotics: Patients whose symptoms are controlled with atypical antipsychotic in once daily formulation (excluding Seroquel SR) and started with the therapy up to 1 month before the inclusion | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | three times: 0, 12 and 24 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | three times: 0, 12 and 24 weeks after inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, Seroquel SR, atypical antipsychotics, assessment of functioning, GAF scale