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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00750087
First received: September 9, 2008
Last updated: February 4, 2010
Last verified: February 2010
History of Changes

September 9, 2008
February 4, 2010
August 2008
September 2009   (final data collection date for primary outcome measure)
Brief Psychiatric Rating Scale - BPRS [ Time Frame: monthly/ at every clinic visit- 7 times ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00750087 on ClinicalTrials.gov Archive Site
  • Clinical Global Impression Severity of Illness - CGI -S [ Time Frame: monthly/ at every clinic visit- 7 times ] [ Designated as safety issue: No ]
  • Clinical Global Impression Improvement CGI -I [ Time Frame: monthly/ at every clinic visit except first visit- 6 times ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF) [ Time Frame: twice/first and last clinic visit ] [ Designated as safety issue: No ]
  • Clinical Global Impression Severity of Illness [ Time Frame: monthly/ at every clinic visit- 7 times ] [ Designated as safety issue: No ]
  • CGI -S Clinical Global Impression Improvement CGI -I [ Time Frame: monthly/ at every clinic visit except first visit- 6 times ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF) [ Time Frame: twice/first and last clinic visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The programme will include schizophrenia patients stabilized on Seroquel XR from community sample
Schizophrenia
Not Provided
1
Schizophrenia patients stabilized on Seroquel XR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
578
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Romania
 
NCT00750087
NIS-NRO-SER-2008/1
No
Hans Eriksson - Medical Science Director, AstraZeenca
AstraZeneca
Not Provided
Study Chair: Beatrice Costea AstraZeneca
AstraZeneca
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP