Nis Register Study Comparing Seroquel and Seroquel Prolong

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. Identifier: NCT00965536
Recruitment Status : Completed
First Posted : August 25, 2009
Last Update Posted : February 16, 2011
Information provided by:

Brief Summary:
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 or disease
Comparing Hospitalisation Time With Seroquel and Seroquel Prolong

Study Type : Observational
Estimated Enrollment : 200 participants
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.
Study Start Date : August 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Seroquel Prolong

Primary Outcome Measures :
  1. Hospitalisation time [ Time Frame: 2008-2010 ]
  2. Treatment practice [ Time Frame: 2008-2010 ]

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

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

Inclusion Criteria:

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

Exclusion Criteria:

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 identifier (NCT number): NCT00965536

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

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

Keywords provided by AstraZeneca:
Bipolar Disorder
Manic Disorder
Register study
Quetiapine Prolong
Seroquel Prolong
Seroquel XR

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