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

October 13, 2011 updated by: AstraZeneca

Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients visiting psychiatrist's practice

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
three times: 0, 12 and 24 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
three times: 0, 12 and 24 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Peter Pregelj, MD, PhD, Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 29, 2009

First Submitted That Met QC Criteria

January 29, 2009

First Posted (Estimate)

February 2, 2009

Study Record Updates

Last Update Posted (Estimate)

October 14, 2011

Last Update Submitted That Met QC Criteria

October 13, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NSI-SER-2008/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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