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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750087
• Other study ID #: NIS-NRO-SER-2008/1
• Status: Completed
• Phase: N/A
• First received: September 9, 2008
• Last updated: February 4, 2010
• Start date: August 2008
• Est. completion date: September 2009

Study information

• Verified date: February 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Romania	Research Site	Alba
Romania	Research Site	Arad
Romania	Research Site	Bacau
Romania	Research Site	Baia Mare
Romania	Research Site	Bistrita
Romania	Research Site	Botosani
Romania	Research Site	Braila
Romania	Research Site	Brasov
Romania	Research Site	Bucuresti
Romania	Research Site	Calarasi
Romania	Research Site	Campina
Romania	Research Site	Cluj
Romania	Research Site	Cluj Napoca
Romania	Research Site	Constanta
Romania	Research Site	Craiova
Romania	Research Site	Deva
Romania	Research Site	Galati
Romania	Research Site	Giurgiu
Romania	Research Site	Horezu
Romania	Research Site	Iasi
Romania	Research Site	Oradea
Romania	Research Site	Pitesti
Romania	Research Site	Ploiesti
Romania	Research Site	Ramnicu Valcea
Romania	Research Site	Satu Mare
Romania	Research Site	Sibiu
Romania	Research Site	Siret
Romania	Research Site	Slatina
Romania	Research Site	Slobozia
Romania	Research Site	Targoviste
Romania	Research Site	Targu Mures
Romania	Research Site	Timisoara
Romania	Research Site	Zalau

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Psychiatric Rating Scale - BPRS		monthly/ at every clinic visit- 7 times	No
Secondary	Clinical Global Impression Severity of Illness - CGI -S		monthly/ at every clinic visit- 7 times	No
Secondary	Clinical Global Impression Improvement CGI -I		monthly/ at every clinic visit except first visit- 6 times	No
Secondary	Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF)		twice/first and last clinic visit	No