Quality of Life in Schizophrenic Patients | NCT00597168 | Trialant

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Quality of Life in Schizophrenic Patients | NCT00597168 | Trialant

Studies
Quality of Life in Schizophrenic Patients

NCT00597168

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jun 9, 2010Estimated

Enrollment

124Actual

Phase

Not provided

Conditions

Schizophrenia

Interventions

Not provided

Countries

Belgium

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

NCT00597168

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

NIS-NBE-SER-2006/1

Secondary IDs

Not provided

Brief Title

Quality of Life in Schizophrenic Patients

Official Title

QUALITY: A Non-interventional Study Evaluating Quality Of Life in Schizophrenic Patients Treated With Atypical Antipsychotics, in the Ambulatory Setting. A 9-month, Observational, Multicentric Prospective Study.

Acronym

Quality

Organization

AstraZenecaINDUSTRY

Status Module

Record Verification Date

Jun 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Oct 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Nov 28, 2007

First Submission Date that Met QC Criteria

Jan 16, 2008

First Posted Date

Jan 17, 2008Estimated

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

Jun 8, 2010

Last Update Posted Date

Jun 9, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

AstraZenecaINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

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

This is a non-interventional study evaluating quality of life in schizophrenic patients treated with atypical antipsychotics, in the ambulatory setting. This is a 9-month, observational, multicentric prospective study.

Detailed Description

Not provided

Conditions Module

Conditions

Schizophrenia

Keywords

Schizophrenia
atypical antipsychotic
quality of life
ambulatory setting

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

124Actual

Arms/Interventions Module

No data available

No data is available for this block.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline of QOL assessed by the SWN-K after 9 months of treatment with AAPs.		9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients diagnosed with Schizophrenia treated with atypical antipsychotics (ambulatory patients).

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Ambulatory patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prof Vermylen	UZ Leuven	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aalst			Belgium
Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Brazil
Bulgaria
Canada
Denmark
Germany
Hungary
Italy
Mexico
Romania
South Africa
United States

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Case-Only

Time Perspective

Prospective

Masking Info

No data available

No data is available for this block.

Asse

Belgium

Research Site

Bertrix

Belgium

Research Site

Bierbeek

Belgium

Research Site

Boechout

Belgium

Research Site

Bon-Secours

Belgium

Research Site

Brussels

Belgium

Research Site

Dendermonde

Belgium

Research Site

Diest

Belgium

Research Site

Duffel

Belgium

Research Site

Eeklo

Belgium

Research Site

Embourg

Belgium

Research Site

Floreffe

Belgium

Research Site

Ghent

Belgium

Research Site

Halle

Belgium

Research Site

Henri-Chapelle

Belgium

Research Site

Herstal

Belgium

Research Site

Ixelles-Elsene

Belgium

Research Site

Jambes

Belgium

Research Site

Kortenberg

Belgium

Research Site

Kortrijk

Belgium

Research Site

La Louvière

Belgium

Research Site

Leut

Belgium

Research Site

Leuven

Belgium

Research Site

Libramont

Belgium

Research Site

Lierneux

Belgium

Research Site

Liège

Belgium

Research Site

Melle

Belgium

Research Site

Menen

Belgium

Research Site

Mol

Belgium

Research Site

Mons

Belgium

Research Site

Ostend

Belgium

Research Site

Ottignies

Belgium

Research Site

Roeselare

Belgium

Research Site

Schaarbeek

Belgium

Research Site

Sint-Kruis (Brugge)

Belgium

Research Site

Sint-Michiels

Belgium

Research Site

Sint-Niklaas

Belgium

Research Site

Sint-Truiden

Belgium

Research Site

Sleidinge

Belgium

Research Site

Tielt

Belgium

Research Site

Tienen

Belgium

Research Site

Veurne

Belgium

Research Site

Waregem

Belgium

Research Site

Woluwe-Saint-Lambert

Belgium

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided