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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00750087
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : February 5, 2010
Information provided by:

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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 578 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study to Observe Treatment Efficacy in Maintaining Symptoms Control in Patients With Schizophrenia, Treated With Seroquel XR
Study Start Date : August 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Schizophrenia patients stabilized on Seroquel XR

Primary Outcome Measures :
  1. Brief Psychiatric Rating Scale - BPRS [ Time Frame: monthly/ at every clinic visit- 7 times ]

Secondary Outcome Measures :
  1. Clinical Global Impression Severity of Illness - CGI -S [ Time Frame: monthly/ at every clinic visit- 7 times ]
  2. Clinical Global Impression Improvement CGI -I [ Time Frame: monthly/ at every clinic visit except first visit- 6 times ]
  3. Quality of Life Enjoyment & Satisfaction Questionnaire - Short Form ( Q - LES - Q - SF) [ Time Frame: twice/first and last clinic visit ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The programme will include schizophrenia patients stabilized on Seroquel XR from community sample

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00750087

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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
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Braila, Romania
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Brasov, Romania
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Bucuresti, Romania
Research Site
Calarasi, Romania
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Campina, Romania
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Cluj Napoca, Romania
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Cluj, Romania
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Constanta, Romania
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Craiova, Romania
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Deva, Romania
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Galati, Romania
Research Site
Giurgiu, Romania
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Horezu, Romania
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Iasi, Romania
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Oradea, Romania
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Pitesti, Romania
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Ploiesti, Romania
Research Site
Ramnicu Valcea, Romania
Research Site
Satu Mare, Romania
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Sibiu, Romania
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Siret, Romania
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Slatina, Romania
Research Site
Slobozia, Romania
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Targoviste, Romania
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Targu Mures, Romania
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Timisoara, Romania
Research Site
Zalau, Romania
Sponsors and Collaborators
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Study Chair: Beatrice Costea AstraZeneca
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Responsible Party: Hans Eriksson - Medical Science Director, AstraZeenca Identifier: NCT00750087    
Other Study ID Numbers: NIS-NRO-SER-2008/1
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: February 5, 2010
Last Verified: February 2010
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders