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

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00833456
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Study Start: 2009-02
• Study First Posted: 2009-02-02
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-13
• Last Update Posted: 2011-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇸🇮 Vojnik, Slovenia