NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia
Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics
1 other identifier
observational
106
1 country
14
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2009
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2009
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedFirst Posted
Study publicly available on registry
February 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedOctober 14, 2011
October 1, 2011
1.7 years
January 29, 2009
October 13, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (2)
1
Seroquel SR: Patients whose symptoms are controlled with Seroquel SR and started with the therapy up to 1 month before the inclusion
2
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
Eligibility Criteria
patients visiting psychiatrist's practice
You may qualify if:
- patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (14)
Research Site
Begunje na Gorenjskem, Slovenia
Research Site
Brezovica pri Ljubljani, Slovenia
Research Site
Brežice, Slovenia
Research Site
Idrija, Slovenia
Research Site
Koper, Slovenia
Research Site
Ljubljana, Slovenia
Research Site
Maribor, Slovenia
Research Site
Nova Gorica, Slovenia
Research Site
Novo Mesto, Slovenia
Research Site
Ormož, Slovenia
Research Site
Postojna, Slovenia
Research Site
Radenci, Slovenia
Research Site
Sežana, Slovenia
Research Site
Vojnik, Slovenia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Pregelj, MD, PhD
Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2009
First Posted
February 2, 2009
Study Start
February 1, 2009
Primary Completion
November 1, 2010
Study Completion
November 1, 2010
Last Updated
October 14, 2011
Record last verified: 2011-10