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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00758251
First received: September 23, 2008
Last updated: December 8, 2010
Last verified: December 2010
  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 April 23, 2014