SchizophreniaXperienceNCT00689325
Evaluating Subjective Well-being in Schizophrenic Patients Treated With quetiapineXR® and Other Atypical Antipsychotics
An observational study of Schizophrenia, run by AstraZeneca at 37 sites in Netherlands.
Trial summary
To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 158 participants
- Where
- 37 sitesNetherlands
- Study dates
- Apr 2008to Jan 2010
- 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: Patients with schizophrenia treated with atypical antipsychotics (AAPs) to stay in remission
Who may be able to join
- Diagnosis of schizophrenia
- Treatment with one atypical antipsychotic* (for a first/new episode or a switch of therapy) for at least 2 weeks and maximum 8 weeks prior to the first study visit.
- Patient takes an AAP according to local SPC and current medical practice
- The patient must be able to understand and comply with the study requirements as judged by the investigator, e.g. patient must be able to read and write
Who cannot join
- Treatment with an additional AAP or AP to the initial prescribed AAP within the 2-8 weeks before the patient is included in the study
- Since the use of clozapine is limited, due to, among other things, the risk for agranulocytosis, patients on treatment with this '2nd line'AAP are excluded.
- Previous enrolment or treatment in the present NIS
- Known allergy to the prescribed AAP or any of its substances
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Netherlands37 sites
Research Site
Alphen
Research Site
Amersfoort
Research Site
Amstelveen
Research Site
Amsterdam
Research Site
Arnhem
Research Site
Bennebroek
Research Site
Boxmeer
Research Site
Breda
Research Site
Doetinchem
Research Site
Echt
Research Site
Enkhuizen
Research Site
Enschede
Research Site
Haarlem
Research Site
Halsteren
Research Site
Helmond
Research Site
Heythuysen
Research Site
Hoorn
Research Site
Kerkrade
Research Site
Kloetinge
Research Site
Leeuwarden
Research Site
Maastricht
Research Site
Nijmegen
Research Site
Oegstgeest
Research Site
Raalte
Research Site
Roermond
Research Site
Rotterdam
Research Site
Sluis
Research Site
Tiel
Research Site
Tilburg
Research Site
Utrecht
Research Site
Veenendaal
Research Site
Venray
Research Site
Vlaardingen
Research Site
Weert
Research Site
Zaandam
Research Site
Zoetermeer
Research Site
Zwolle
About this study
Official title: A Non-interventional Study Evaluating Well-being/Quality of Life in Schizophrenic Patients Treated With Seroquel XR® (Quetiapine) and Other Atypical Antipsychotics.A 9-month, Observational, Multicentric Prospective Study.
To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, remission, subjective well-being and effectiveness, Quality of Life
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Wellbeing under Neuroleptics' SWN-K-score; Change from baseline of QoL assessed by the SWN-K after 9 months of treatment with atypical antipsychotics.
Measured: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Secondary outcomes (3)
Positive And Negative Syndrome Scale-PANSS-8score
Measured: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Global Assessment of Functioning 'GAF' scale
Measured: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Disease insight; G-12 item of PANSS
Measured: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionJan 2010
- Study completionJan 2010
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
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00689325
- Sponsor's protocol ID
- NIS-NNL-SER-2008/1
- Acronym
- Xperience
- Status last verified
- Oct 2010
- First submitted
- 29 May 2008
- Last updated
- 27 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study Evaluating Well-being/Quality of Life in Schizophrenic Patients Treated With Seroquel XR® (Quetiapine) and Other Atypical Antipsychotics.A 9-month, Observational, Multicentric Prospective Study.
- ClinicalTrials.gov ID
- NCT00689325
- Acronym / sponsor ID
- Xperience / NIS-NNL-SER-2008/1
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, remission, subjective well-being and effectiveness, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 Jun 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.
To evaluate the QOL (subjective effectiveness) in patients with schizophrenia, treated with atypical antipsychotics.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with schizophrenia treated with atypical antipsychotics (AAPs) to stay in remission
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia
- Treatment with one atypical antipsychotic* (for a first/new episode or a switch of therapy) for at least 2 weeks and maximum 8 weeks prior to the first study visit.
- Patient takes an AAP according to local SPC and current medical practice
- The patient must be able to understand and comply with the study requirements as judged by the investigator, e.g. patient must be able to read and write
Key exclusion criteria (4 listed)
- Treatment with an additional AAP or AP to the initial prescribed AAP within the 2-8 weeks before the patient is included in the study
- Since the use of clozapine is limited, due to, among other things, the risk for agranulocytosis, patients on treatment with this '2nd line'AAP are excluded.
- Previous enrolment or treatment in the present NIS
- Known allergy to the prescribed AAP or any of its substances
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
Subjective Wellbeing under Neuroleptics' SWN-K-score; Change from baseline of QoL assessed by the SWN-K after 9 months of treatment with atypical antipsychotics.
Time frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
3 secondary outcomes
Positive And Negative Syndrome Scale-PANSS-8score
Time frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Global Assessment of Functioning 'GAF' scale
Time frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
Disease insight; G-12 item of PANSS
Time frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation
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 27 Oct 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
37 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 37 sites in Netherlands.
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 4 inclusion and 4 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 27 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in Netherlands. 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?
Subjective Wellbeing under Neuroleptics' SWN-K-score; Change from baseline of QoL assessed by the SWN-K after 9 months of treatment with atypical antipsychotics. (time frame: At baseline (Visit 1), and after ~3 months, ~6 months, ~9 months after V1, or at premature discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2010.