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Observation of Change in Clinical Global Impression Scores in Schizophrenia Patients Receiving Seroquel XR Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00758251
First Posted: September 25, 2008
Last Update Posted: December 10, 2010
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.
Information provided by:
AstraZeneca
  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 ]

Secondary Outcome Measures:
  • To evaluate compliance to therapy [ Time Frame: twice with 4 week interval ]

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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

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
First Submitted: September 23, 2008
First Posted: September 25, 2008
Last Update Posted: December 10, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Schizophrenia
Seroquel XR
CGI

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