Nis Register Study Comparing Seroquel and Seroquel Prolong - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00965536

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:

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Hospitalisation time [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]
Treatment practice [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Primary diagnosis [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]
Medication at the end of hospitalisation [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]
GAF rating points [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:	Both
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:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party:	MC MD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00965536 History of Changes
Other Study ID Numbers:	NIS-NFI-SER-2009/1
Study First Received:	August 24, 2009
Last Updated:	February 15, 2011
Health Authority:	Finland: Finnish Medicines Agency

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
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 February 09, 2012