Subjective Well Being of Schizophrenic Patients in Greece (AURA)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00857064
First received: March 3, 2009
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

Non-interventional study aiming to provide data on the subjective effects of antipsychotic medication assessing subjective well-being and global functioning of patients with Schizophrenia under antipsychotic medication. Moreover it aims to assess their adherence to the treatment and will investigate whether there is any correlation of these factors with the clinical condition of these patients.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Subjective Well Being of Schizophrenic Patients in Greece

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Assessment of Subjective well being [ Time Frame: Relative score reported in SWBN scale at the visit. No baseline comparison ] [ Designated as safety issue: No ]
  • Assessment of functioning [ Time Frame: Relative score reported in GAF scale at the visit. No baseline comparison ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of Compliance to therapy [ Time Frame: Relative score reported in BARS scale at the visit. No baseline comparison ] [ Designated as safety issue: No ]
  • Assessment of General Psychopathology [ Time Frame: Relative score reported in PANNS scale at the visit. No baseline comparison ] [ Designated as safety issue: No ]
  • Assessment of Clinical Condition [ Time Frame: Relative score reported in CGIS scale at the visit. No baseline comparison ] [ Designated as safety issue: No ]

Enrollment: 600
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Target Group:Patients suffering from Schizophrenia treated in private practice

Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Diagnosis of schizophrenia according to DSM-IV
  • The patient must have been prescribed an atypical antipsychotic for at least 4 weeks before the first study visit

Exclusion Criteria:

-

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857064

Locations
Greece
Research Site
Agrinio, Greece
Research Site
Alexsandroupoli, Greece
Research Site
Argos, Greece
Research Site
Arta, Greece
Research Site
Athens, Greece
Research Site
Crete, Greece
Research Site
Drama, Greece
Research Site
Edessa, Greece
Research Site
Elefsina, Greece
Research Site
Giannitsa, Greece
Research Site
Ioannina, Greece
Research Site
Karditsa, Greece
Research Site
Katerini, Greece
Research Site
Kavala, Greece
Research Site
Kozani, Greece
Research Site
Larisa, Greece
Research Site
Patra, Greece
Research Site
Peiraias, Greece
Research Site
Preveza, Greece
Research Site
Rodos, Greece
Research Site
Serres, Greece
Research Site
Thessalonica, Greece
Research Site
Thiva, Greece
Research Site
Volos, Greece
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Errikos Tzempelikos, Dr Sismanoglio Hospital, Psychiatric Department, Greece
  More Information

No publications provided

Responsible Party: Dr Pontikis Panagiotis, MD Medical and Regulatory Affairs Director, AstraZeneca, SA Greece
ClinicalTrials.gov Identifier: NCT00857064     History of Changes
Other Study ID Numbers: NIS-NGR-DUM-2008/2
Study First Received: March 3, 2009
Last Updated: December 7, 2010
Health Authority: Greece: National Organization of Medicines

Keywords provided by AstraZeneca:
Schizophrenia
antipsychotics
social functioning
subjective well being
Patients suffering from Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014