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NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00833456
First received: January 29, 2009
Last updated: October 13, 2011
Last verified: October 2011
History of Changes
  Purpose

The purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline and the last study visit. The secondary study objectives are to compare general functioning of patients with schizophrenia treated with other atypical antipsychotic medicinal products administered once daily between baseline and the last study visit, monitoring of other indicators of clinical improvement, evaluation of patient compliance and assessment of occurrence of adverse effects


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group. [ Time Frame: three times: 0, 12 and 24 weeks after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the group of patients treated with other atypical antipsychotics [ Time Frame: three times: 0, 12 and 24 weeks after inclusion ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: February 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Seroquel SR: Patients whose symptoms are controlled with Seroquel SR and started with the therapy up to 1 month before the inclusion
2
Atypical antipsychotics: Patients whose symptoms are controlled with atypical antipsychotic in once daily formulation (excluding Seroquel SR) and started with the therapy up to 1 month before the inclusion

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients visiting psychiatrist's practice

Criteria

Inclusion Criteria:

  • patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
  • patients' symptoms are controlled with Seroquel SR started up to 1 month before the inclusion
  • or patients' symptoms are controlled with other atypical antipsychotic in once daily formulation started up to 1 month before the inclusion

Exclusion Criteria:

  • patients who are treated with Seroquel SR or other antipsychotic more than 1 month
  • patients with prescribed antipsychotic combinations
  • pregnant women or women who are breast-feeding
  • patients who have been treated with antipsychotics in depot formulations for the last two months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833456

Locations
Slovenia
Research Site
Begunje, Slovenia
Research Site
Brezice, Slovenia
Research Site
Brezovica pri Ljubljani, Slovenia
Research Site
Idrija, Slovenia
Research Site
Koper, Slovenia
Research Site
Ljubljana, Slovenia
Research Site
Maribor, Slovenia
Research Site
Nova Gorica, Slovenia
Research Site
Novo Mesto, Slovenia
Research Site
Ormoz, Slovenia
Research Site
Postojna, Slovenia
Research Site
Radenci, Slovenia
Research Site
Sezana, Slovenia
Research Site
Vojnik, Slovenia
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Peter Pregelj, MD, PhD Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00833456     History of Changes
Other Study ID Numbers: NIS-NSI-SER-2008/1
Study First Received: January 29, 2009
Last Updated: October 13, 2011
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by AstraZeneca:
schizophrenia
Seroquel SR
atypical antipsychotics
assessment of functioning
GAF scale

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
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 June 18, 2013