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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00833456
• Other study ID #: NIS-NSI-SER-2008/1
• Status: Completed
• Phase: N/A
• First received: January 29, 2009
• Last updated: October 13, 2011
• Start date: February 2009
• Est. completion date: November 2010

Study information

• Verified date: October 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Agency for Medicinal Products - Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Slovenia	Research Site	Begunje
Slovenia	Research Site	Brezice
Slovenia	Research Site	Brezovica pri Ljubljani
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	Ormoz
Slovenia	Research Site	Postojna
Slovenia	Research Site	Radenci
Slovenia	Research Site	Sezana
Slovenia	Research Site	Vojnik

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No