Nis Register Study Comparing Seroquel and Seroquel Prolong | NCT00965536

Studies
Nis Register Study Comparing Seroquel and Seroquel Prolong

NCT00965536

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Feb 16, 2011Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Comparing Hospitalisation Time With Seroquel and Seroquel Prolong

Interventions

Not provided

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 24, 2009

First Submission Date that Met QC Criteria

Aug 24, 2009

First Posted Date

Aug 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2011

Last Update Posted Date

Feb 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Seroquel
2		Seroquel Prolong

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospitalisation time		2008-2010
Treatment practice		2008-2010

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

South Karelia Central Hospital in-patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yrjö Ovaskainen	Medical Affairs Manager, MD, psychiatrist	Study Director
Kari Hänninen	MD, psychiatrist	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lappeenranta			Finland

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia
D001714	Bipolar Disorder

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders

Browse Leaves

Not provided

Browse Branches

Not provided