Non-interventional Study -Observe Treatment Efficacy in Maintaining Symptoms Control in Schizophrenia With Seroquel XR

Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00750087

Enrollment

578

Registered

2008-09-10

Start date

2008-08-31

Completion date

2009-09-30

Last updated

2010-02-05

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

Conditions

Schizophrenia

Keywords

Schizophrenia

Brief summary

the primary purpose of the study is to observe symptoms control in schizophrenia for 6 months in patients treated with Seroquel XR. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients will have a diagnosis of schizophrenia , as defined by DSM-IV-TR and their symptoms are controlled with Seroquel XR therapy started approximately 1 month before * All eligible patients will be included in the protocol provided they will receive detailed information in advance and will sign consent to grant access to their own data collected during this programme.

Exclusion criteria

* All the patients who have a known hypersensitivity to Seroquel XR/quetiapine or any of its excipients will not be included in this study. * As per valid Romanian SmPC, concomitant medication, that could result in drug interactions and could jeopardise patient safety will be carefully considered before having the patient enrolled.

Design outcomes

Primary

Measure	Time frame
Brief Psychiatric Rating Scale - BPRS	monthly/ at every clinic visit- 7 times

Secondary

Measure	Time frame
Clinical Global Impression Severity of Illness - CGI -S	monthly/ at every clinic visit- 7 times
Clinical Global Impression Improvement CGI -I	monthly/ at every clinic visit except first visit- 6 times
Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF)	twice/first and last clinic visit

Countries

Romania

Outcome results