Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00921362
First received: June 15, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme

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 [ 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 ]

Enrollment: 1387
Study Start Date: May 2006
Study Completion Date: January 2007
Groups/Cohorts
1
Schizophrenia patients under Seroquel treatment

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921362

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

No publications provided

ClinicalTrials.gov Identifier: NCT00921362     History of Changes
Other Study ID Numbers: NIS-NRO-SER-2006/2, SER-01-S-06
Study First Received: June 15, 2009
Last Updated: June 15, 2009
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 April 17, 2014