Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00758251
First received: September 23, 2008
Last updated: December 8, 2010
Last verified: December 2010
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Purpose
The purpose of this study is to assess severity of illness in schizophrenia patients in routine clinical practice at the time of entry in the study and after the treatment with Seroquel XR for 8 weeks.
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: Case-Only Time Perspective: Prospective |
| Official Title: | Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Improvement in CGI scores and BPRS comparing visits 1 and 3. [ Time Frame: twice with 4 week interval ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate compliance to therapy [ Time Frame: twice with 4 week interval ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Adult schizophrenia patients already on Seroquel XR therapy
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
primary care clinics
Criteria
Inclusion Criteria:
- Adult patients with Schizophrenia prescribed on Seroquel XR according to the approved product information before inclusion in this non-interventional study
- Signed and dated Patient Informed Consent (ICF)
Exclusion Criteria:
- Hypersensitivity to the active substance or to any of the excipients of Seroquel XR
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758251
Locations
| Latvia | |
| Research Site | |
| Bauska, Latvia | |
| Research SIte | |
| Cesis, Latvia | |
| Research Site | |
| Daugavpils, Latvia | |
| Research Site | |
| Dobele, Latvia | |
| Research Site | |
| Jekabpils, Latvia | |
| Research Site | |
| Jelgava, Latvia | |
| Research Site | |
| Jurmala, Latvia | |
| Research Site | |
| Kuldiga, Latvia | |
| Research Site | |
| Liepaja, Latvia | |
| Research Site | |
| Riga, Latvia | |
| Research Site | |
| Saldus, Latvia | |
| Research Site | |
| Strenci, Latvia | |
| Research Site | |
| Talsi, Latvia | |
| Research Site | |
| Tukums, Latvia | |
| Research Site | |
| Valmiera, Latvia | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Agrita Hartmane | AstraZeneca Latvia |
More Information
No publications provided
| Responsible Party: | Janis Dobelis, Country Manager, AstraZeneca MC Latvia |
| ClinicalTrials.gov Identifier: | NCT00758251 History of Changes |
| Other Study ID Numbers: | NIS-NLV-SER-2008/1 |
| Study First Received: | September 23, 2008 |
| Last Updated: | December 8, 2010 |
| Health Authority: | Latvia: State Agency of Medicines |
Keywords provided by AstraZeneca:
|
Schizophrenia Seroquel XR CGI |
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