Clinical trial NCT00833456: NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia
Official title: Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: schizophrenia
Seroquel SR
atypical antipsychotics
assessment of functioning
GAF scale
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-02-02
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients visiting psychiatrist's practice

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


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: three times: 0, 12 and 24 weeks after inclusion
Secondary outcomes:
measure: 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
timeFrame: three times: 0, 12 and 24 weeks after inclusion
Other outcomes:
Locations:
city: Begunje
country: Slovenia
facility: Research Site
city: Brezice
country: Slovenia
facility: Research Site
city: Brezovica pri Ljubljani
country: Slovenia
facility: Research Site
city: Idrija
country: Slovenia
facility: Research Site
city: Koper
country: Slovenia
facility: Research Site
city: Ljubljana
country: Slovenia
facility: Research Site
city: Maribor
country: Slovenia
facility: Research Site
city: Nova Gorica
country: Slovenia
facility: Research Site
city: Novo Mesto
country: Slovenia
facility: Research Site
city: Ormoz
country: Slovenia
facility: Research Site
city: Postojna
country: Slovenia
facility: Research Site
city: Radenci
country: Slovenia
facility: Research Site
city: Sezana
country: Slovenia
facility: Research Site
city: Vojnik
country: Slovenia
facility: Research Site
Study officials:
affiliation: Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana
name: Peter Pregelj, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: