Subjective Well Being of Schizophrenic Patients in Greece - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00857064

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:	Case-Only, Cross-Sectional
Official Title:	Subjective Well Being of Schizophrenic Patients in Greece

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	March 2009
Estimated Study Completion Date:	May 2009

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

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

Contacts

Contact: AstraZeneca Greece Medical Affairs and Health Economics, Clinical Study Information

00302106871540

Panagiotis.Pontikis@astrazeneca.com

Locations

Greece
Research Site	Completed
AGRINIO, Greece
Research Site	Completed
ALEXSANDROUPOLI, Greece
Research Site	Completed
ARGOS, Greece
Research Site	Completed
ARTA, Greece
Research Site	Completed
ATHENS, Greece
Research Site	Completed
CRETE, Greece
Research Site	Completed
DRAMA, Greece
Research Site	Completed
EDESSA, Greece
Research Site	Completed
ELEFSINA, Greece
Research Site	Completed
GIANNITSA, Greece
Research Site	Recruiting
IOANNINA, Greece
Research Site	Completed
KARDITSA, Greece
Research Site	Completed
VOLOS, Greece
Research Site	Completed
KAVALA, Greece
Research Site	Completed
KOZANI, Greece
Research Site	Completed
LARISA, Greece
Research Site	Completed
PATRA, Greece
Research Site	Completed
PEIRAIAS, Greece
Research Site	Completed
PREVEZA, Greece
Research Site	Completed
RODOS, Greece
Research Site	Completed
SERRES, Greece
Research Site	Completed
THESSALONICA, Greece
Research Site	Completed
THIVA, Greece
Research Site	Completed
KATERINI, Greece

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Errikos Tzempelikos, Dr

Sismanoglio Hospital, Psychiatric Department, Greece

More Information

No publications provided

Responsible Party:	AstraZeneca, SA Greece ( Dr Pontikis Panagiotis, MD Medical and Regulatory Affairs Director )
Study ID Numbers:	NIS-NGR-DUM-2008/2
Study First Received:	March 3, 2009
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00857064 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by AstraZeneca:

Schizophrenia
antipsychotics
social functioning
subjective well being
Patients suffering from Schizophrenia

Study placed in the following topic categories:

Schizophrenia
Mental Disorders
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 10, 2009