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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00833456

Enrollment

106

Registered

2009-02-02

Start date

2009-02-28

Completion date

2010-11-30

Last updated

2011-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

schizophrenia, Seroquel SR, atypical antipsychotics, assessment of functioning, GAF scale

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Slovenia

Outcome results