Non-interventional Study -Observe Treatment Efficacy in Maintaining Symptoms Control in Schizophrenia With Seroquel XR
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00750087
First received: September 9, 2008
Last updated: February 4, 2010
Last verified: February 2010
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Purpose
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 |
|---|
|
Schizophrenia |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Brief Psychiatric Rating Scale - BPRS [ Time Frame: monthly/ at every clinic visit- 7 times ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 578 |
| Study Start Date: | August 2008 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Schizophrenia patients stabilized on Seroquel XR
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
The programme will include schizophrenia patients stabilized on Seroquel XR from community sample
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750087
Locations
| Romania | |
| Research Site | |
| Alba, Romania | |
| Research Site | |
| Arad, Romania | |
| Research Site | |
| Bacau, Romania | |
| Research Site | |
| Baia Mare, Romania | |
| Research Site | |
| Bistrita, Romania | |
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| Botosani, Romania | |
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| Braila, Romania | |
| Research Site | |
| Brasov, Romania | |
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| Bucuresti, Romania | |
| Research Site | |
| Calarasi, Romania | |
| Research Site | |
| Campina, Romania | |
| Research Site | |
| Cluj, Romania | |
| Research Site | |
| Cluj Napoca, Romania | |
| Research Site | |
| Constanta, Romania | |
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| 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 | |
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| Ploiesti, Romania | |
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| 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, Romania | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Chair: | Beatrice Costea | AstraZeneca |
More Information
No publications provided
| Responsible Party: | Hans Eriksson - Medical Science Director, AstraZeenca |
| ClinicalTrials.gov Identifier: | NCT00750087 History of Changes |
| Other Study ID Numbers: | NIS-NRO-SER-2008/1 |
| Study First Received: | September 9, 2008 |
| Last Updated: | February 4, 2010 |
| Health Authority: | Romania: National Medicines Agency |
Keywords provided by AstraZeneca:
|
Schizophrenia |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Quetiapine Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 18, 2013