Quality of Life in SchizophreniaPASQALNCT00934726
Non-interventional Open Label Study to Investigate the Effect of Quetiapine XR on Patient Satisfaction and Quality of Life in Patients With Schizophrenia
An observational study of Quality of Life in Schizophrenia, run by AstraZeneca.
Trial summary
Since subjective well-being and quality of life (QoL) are increasingly being recognized as important treatment outcomes in patients with schizophrenia (Hofer et al., 2004; Becker et al., 2005), the aim of this study is to investigate the effect of treatment with quetiapine XR on these parameters in the acute hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life in Schizophrenia
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The psychiatrists according to inclusion criteria select patients.
Who may be able to join
- Adult schizophrenia patients
Who cannot join
- Diagnosis other than schizophrenia
- Patients for which Seroquel XR is not registered (pregnant women, children and adolescents…)
About this study
Official title: Patient Satisfaction and Quality of Life Under Treatment With Seroquel XR
Since subjective well-being and quality of life (QoL) are increasingly being recognized as important treatment outcomes in patients with schizophrenia (Hofer et al., 2004; Becker et al., 2005), the aim of this study is to investigate the effect of treatment with quetiapine XR on these parameters in the acute hospital and the subsequent ambulant care setting. The study is planned to be conducted in 15 centers all over Austria and, overall, about 150 inpatients with a ICD-10 diagnosis of acute schizophrenia are planning to be enrolled. The duration of the whole trial will be approximately 4 months, whereas 2 visits during hospitalization and two further visits after discharge will be scheduled. At each visit, adverse events and safety parameters, patient satisfaction and effectiveness of the current treatment, as well as concomitant medication and dosing schedules will be assessed and documented.In addition to that, the patients' overall satisfaction with antipsychotic therapy and their current quality of life will be determined using a QoL questionnaire, focussing on the subjective experience with quetiapine XR.
- Conditions
- Quality of Life in Schizophrenia
- Keywords
- Quality of Life, Patient satisfaction, Schizophrenia, Investigate quality of life in schizophrenia
- Medical subject headings
- Patient Satisfaction, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 group, schizophrenia patients | Patients with schizophrenia according to ICD-10(diagnostic and statistical manual of mental disorders) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject wellbeing under Neuroleptics scale (Quality of Life)
Measured: 4 months
Secondary outcomes (3)
BPRS (Brief Psychiatric Rating Scale)
Measured: 4 months
CGI (Clinical Global Impression)
Measured: 4 months
All adverse events occurring during the study will be documented
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Life in 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Siegfried Kasper, Prof., Principal investigator, AKH Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934726
- Sponsor's protocol ID
- NIS-NAT-SER-2008/1
- Acronym
- PASQAL
- Status last verified
- Sep 2011
- First submitted
- 7 Jul 2009
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Quality of Life Under Treatment With Seroquel XR
- ClinicalTrials.gov ID
- NCT00934726
- Acronym / sponsor ID
- PASQAL / NIS-NAT-SER-2008/1
- Conditions
- Quality of Life in Schizophrenia
- Keywords
- Quality of Life, Patient satisfaction, Schizophrenia, Investigate quality of life in schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 8 Jul 2009 (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.
Since subjective well-being and quality of life (QoL) are increasingly being recognized as important treatment outcomes in patients with schizophrenia (Hofer et al., 2004; Becker et al., 2005), the aim of this study is to investigate the effect of treatment with quetiapine XR on these parameters in the acute hospital and the subsequent ambulant care setting. The study is planned to be conducted in 15 centers all over Austria and, overall, about 150 inpatients with a ICD-10 diagnosis of acute schizophrenia are planning to be enrolled. The duration of the whole trial will be approximately 4 months, whereas 2 visits during hospitalization and two further visits after discharge will be scheduled. At each visit, adverse events and safety parameters, patient satisfaction and effectiveness of the current treatment, as well as concomitant medication and dosing schedules will be assessed and documented.In addition to that, the patients' overall satisfaction with antipsychotic therapy and their current quality of life will be determined using a QoL questionnaire, focussing on the subjective experience with quetiapine XR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 group, schizophrenia patients | – | –Patients with schizophrenia according to ICD-10(diagnostic and statistical manual of mental disorders) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The psychiatrists according to inclusion criteria select patients.
Key inclusion criteria (1 listed)
- Adult schizophrenia patients
Key exclusion criteria (2 listed)
- Diagnosis other than schizophrenia
- Patients for which Seroquel XR is not registered (pregnant women, children and adolescents…)
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
Subject wellbeing under Neuroleptics scale (Quality of Life)
Time frame: 4 months
3 secondary outcomes
BPRS (Brief Psychiatric Rating Scale)
Time frame: 4 months
CGI (Clinical Global Impression)
Time frame: 4 months
All adverse events occurring during the study will be documented
Time frame: 4 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 23 Sep 2011.
Related trials for Quality of Life in Schizophrenia
RecruitingObservational study
Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective Disorder
Schizophrenia, Bipolar Affective Disorder
Recruiting
Improving Heart and Metabolic Health in People With Severe Mental Illness Through a Long-term Clinical Trial
Psychotic Disorders
Recruiting
Investigation of the Effects of Angling as Supportive Therapy in Schizophrenia Treatment on Serum Parameters, Anxiety, Depression, and Quality of Life
Angling, Supportive Therapeutic
Not yet recruitingPhase 3
A Study Evaluating the Efficacy of Xanomeline/Trospium (XT) on Cognitive Impairment After 24 and 52 Weeks of Treatment in Adult Participants With Schizophrenia
Schizophrenia; Psychosis, Cognitive Impairment
Active, not recruiting
The Acupuncture Treatment Effect in Patients With Schizophrenia
Mental Health
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.
Siegfried Kasper, Prof. principal investigator
AKH Vienna
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life in Schizophrenia, run by AstraZeneca.
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 2 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 23 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Subject wellbeing under Neuroleptics scale (Quality of Life) (time frame: 4 months). 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 23 Sep 2011.