Quality of Life in Schizophrenic Patients

An observational study of Schizophrenia, run by AstraZeneca at 45 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
How many people: 124 participants
Where: 45 sitesBelgium
Study dates: Oct 2007to Oct 2009
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Ambulatory patients

Who may be able to join

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

Who cannot join

None listed.

Trial locations and contacts

45 sites in 1 country.

City, postcode or hospital

45 sites in 1 country

Belgium45 sites

Research Site
Aalst
Research Site
Asse
Research Site
Bertrix
Research Site
Bierbeek
Research Site
Boechout
Research Site
Bon-Secours
Research Site
Brussels
Research Site
Dendermonde
Research Site
Diest
Research Site
Duffel
Research Site
Eeklo
Research Site
Embourg
Research Site
Floreffe
Research Site
Ghent
Research Site
Halle
Research Site
Henri-Chapelle
Research Site
Herstal
Research Site
Ixelles-Elsene
Research Site
Jambes
Research Site
Kortenberg
Research Site
Kortrijk
Research Site
La Louvière
Research Site
Leut
Research Site
Leuven
Research Site
Libramont
Research Site
Liège
Research Site
Lierneux
Research Site
Melle
Research Site
Menen
Research Site
Mol
Research Site
Mons
Research Site
Ostend
Research Site
Ottignies
Research Site
Roeselare
Research Site
Schaarbeek
Research Site
Sint-Kruis (Brugge)
Research Site
Sint-Michiels
Research Site
Sint-Niklaas
Research Site
Sint-Truiden
Research Site
Sleidinge
Research Site
Tielt
Research Site
Tienen
Research Site
Veurne
Research Site
Waregem
Research Site
Woluwe-Saint-Lambert

Other trials in Belgium

About this study

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.

Conditions: Schizophrenia
Keywords: Schizophrenia, atypical antipsychotic, quality of life, ambulatory setting
Medical subject headings: Schizophrenia

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline of QOL assessed by the SWN-K after 9 months of treatment with AAPs.
Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007Oct 2009

First posted17 Jan 2008 (estimated)
Study startOct 2007
Primary completionOct 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00597168
Sponsor's protocol ID: NIS-NBE-SER-2006/1
Acronym: Quality
Status last verified: Jun 2010
First submitted: 28 Nov 2007
Last updated: 9 Jun 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00597168
Acronym / sponsor ID: Quality / NIS-NBE-SER-2006/1
Conditions: Schizophrenia
Keywords: Schizophrenia, atypical antipsychotic, quality of life, ambulatory setting
Study type: Observational
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: Oct 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 17 Jan 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Ambulatory patients

Key inclusion criteria (1 listed)

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

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change from baseline of QOL assessed by the SWN-K after 9 months of treatment with AAPs.
Time frame: 9 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2010.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof Vermylen principal investigator

UZ Leuven

45 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia, run by AstraZeneca at 45 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline of QOL assessed by the SWN-K after 9 months of treatment with AAPs. (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00597168.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2010.