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

AstraZeneca

Status: Completed

Conditions: Schizophrenia

Study type: Observational

Funder types: Industry

Identifiers

NCT00833456

NIS-NSI-SER-2008/1

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

106 participants in 2 patient groups

1

Description:

Seroquel SR: Patients whose symptoms are controlled with Seroquel SR and started with the therapy up to 1 month before the inclusion

2

Description:

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