Clinical trial NCT00750087: Non-interventional Study -Observe Treatment Efficacy in Maintaining Symptoms Control in Schizophrenia With Seroquel XR
Official title: Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 578
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The programme will include schizophrenia patients stabilized on Seroquel XR from community sample

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Brief Psychiatric Rating Scale - BPRS
timeFrame: monthly/ at every clinic visit- 7 times
Secondary outcomes:
measure: Clinical Global Impression Severity of Illness - CGI -S
timeFrame: monthly/ at every clinic visit- 7 times
measure: Clinical Global Impression Improvement CGI -I
timeFrame: monthly/ at every clinic visit except first visit- 6 times
measure: Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF)
timeFrame: twice/first and last clinic visit
Other outcomes:
Locations:
city: Alba
country: Romania
facility: Research Site
city: Arad
country: Romania
facility: Research Site
city: Bacau
country: Romania
facility: Research Site
city: Baia Mare
country: Romania
facility: Research Site
city: Bistrita
country: Romania
facility: Research Site
city: Botosani
country: Romania
facility: Research Site
city: Braila
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Calarasi
country: Romania
facility: Research Site
city: Campina
country: Romania
facility: Research Site
city: Cluj Napoca
country: Romania
facility: Research Site
city: Cluj
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Deva
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Giurgiu
country: Romania
facility: Research Site
city: Horezu
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Ploiesti
country: Romania
facility: Research Site
city: Ramnicu Valcea
country: Romania
facility: Research Site
city: Satu Mare
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Siret
country: Romania
facility: Research Site
city: Slatina
country: Romania
facility: Research Site
city: Slobozia
country: Romania
facility: Research Site
city: Targoviste
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Zalau
country: Romania
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Beatrice Costea
role: STUDY_CHAIR
References: