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Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

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ClinicalTrials.gov Identifier: NCT00921362
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : June 16, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
Patients eligible for entry into the study have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms changes over 6 months in schizophrenia in patients treated with Seroquel; additionally disease severity and treatment compliance are followed

Condition or disease
Schizophrenia

Study Type : Observational
Actual Enrollment : 1387 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme
Study Start Date : May 2006
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Group/Cohort
1
Schizophrenia patients under Seroquel treatment



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 [ Time Frame: Monthly/ at every clinic visit-7 times ]
  2. CGI-S Clinical Global Impression Improvement CGI -I [ Time Frame: Monthly/ at every clinic visit except first visit- 6 times ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients eligible for entry into the study will have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature
Criteria

Inclusion Criteria:

  • To assess at baseline and after treatment administration the severity of the illness in patients with schizophrenia, using the scores obtained after the application of the CGI scale
  • To assess the changes in symptoms of patients treated with Seroquel for 24 weeks, using BPRS (Brief Psychiatry Rating Scale) as measuring tool

Exclusion Criteria:

  • All the patients who have a known hypersensitivity to Seroquel /quetiapine or any of its excipients will not be included in this study.

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 ClinicalTrials.gov identifier (NCT number): NCT00921362


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: stina Pentiuc, Med Director AstraZeneca Romania

ClinicalTrials.gov Identifier: NCT00921362     History of Changes
Other Study ID Numbers: NIS-NRO-SER-2006/2
SER-01-S-06
First Posted: June 16, 2009    Key Record Dates
Last Update Posted: June 16, 2009
Last Verified: June 2009

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs