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Subjective Well Being of Schizophrenic Patients in Greece (AURA)

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ClinicalTrials.gov Identifier: NCT00857064
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : December 9, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease
Schizophrenia

Study Design

Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Subjective Well Being of Schizophrenic Patients in Greece
Study Start Date : March 2009
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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

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
First Posted: March 6, 2009    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders