Nis Register Study Comparing Seroquel and Seroquel Prolong

February 15, 2011 updated by: AstraZeneca

A Local Non Interventional Retrospective Register Study of the Current Clinical Treatment Practices and the Number of Hospitalization Days With Seroquel or Seroquel Prolong.

The general aim of this non interventional study is to clarify what are the current clinical treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release. The primary objectives of the study are:1.To collect information on the used Quetiapine Immediate Release or Quetiapine Extended Release medication 2.To collect information on duration and number of hospitalisation days 3.Change of GAF points

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

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

  • Finland
      • Lappeenranta, Finland
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

South Karelia Central Hospital in-patients

Description

Inclusion Criteria:

  • Medication: Seroquel or Seroquel Prolong
  • Diagnosis: F20-F29 or F30-F31 (ICD-10)
  • In-patient

Exclusion Criteria:

  • None

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
2
Seroquel Prolong

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospitalisation time
Time Frame: 2008-2010
2008-2010
Treatment practice
Time Frame: 2008-2010
2008-2010

Secondary Outcome Measures

Outcome Measure
Time Frame
Primary diagnosis
Time Frame: 2008-2010
2008-2010
Medication at the end of hospitalisation
Time Frame: 2008-2010
2008-2010
GAF rating points
Time Frame: 2008-2010
2008-2010

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Yrjö Ovaskainen, Medical Affairs Manager, MD, psychiatrist
  • Principal Investigator: Kari Hänninen, MD, psychiatrist

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

August 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (Estimate)

August 25, 2009

Study Record Updates

Last Update Posted (Estimate)

February 16, 2011

Last Update Submitted That Met QC Criteria

February 15, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NIS-NFI-SER-2009/1

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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