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Nis Register Study Comparing Seroquel and Seroquel Prolong

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965536
First Posted: August 25, 2009
Last Update Posted: February 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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

Condition
Comparing Hospitalisation Time With Seroquel and Seroquel Prolong

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Local Non Interventional Retrospective Register Study of the Current Clinical Treatment Practices and the Number of Hospitalization Days With Seroquel or Seroquel Prolong.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Hospitalisation time [ Time Frame: 2008-2010 ]
  • Treatment practice [ Time Frame: 2008-2010 ]

Secondary Outcome Measures:
  • Primary diagnosis [ Time Frame: 2008-2010 ]
  • Medication at the end of hospitalisation [ Time Frame: 2008-2010 ]
  • GAF rating points [ Time Frame: 2008-2010 ]

Estimated Enrollment: 200
Study Start Date: August 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Seroquel
2
Seroquel Prolong

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
South Karelia Central Hospital in-patients
Criteria

Inclusion Criteria:

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

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): NCT00965536


Locations
Finland
Research Site
Lappeenranta, Finland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Yrjö Ovaskainen Medical Affairs Manager, MD, psychiatrist
Principal Investigator: Kari Hänninen MD, psychiatrist
  More Information

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00965536     History of Changes
Other Study ID Numbers: NIS-NFI-SER-2009/1
First Submitted: August 24, 2009
First Posted: August 25, 2009
Last Update Posted: February 16, 2011
Last Verified: February 2011

Keywords provided by AstraZeneca:
Schizophrenia
Bipolar Disorder
Manic Disorder
Register study
Quetiapine
Quetiapine Prolong
Seroquel
Seroquel Prolong
Seroquel XR
In-patient

Additional relevant MeSH terms:
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs