SchizophreniaNCT01793324
EMR Data to Assess Monitoring of Patients Treated With Quetiapine
An observational study of Schizophrenia and Bipolar Disorder, run by AstraZeneca.
Trial summary
A study to evaluate the effectiveness of an update of educational materials with respect to evaluation of monitoring of metabolic parameters Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- How many people
- 6,153 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Jun 2013
- 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: Cross sectional assessment of physician encounters with patients
Who may be able to join
- Electronic medical records of patients with diagnoses of schizophrenia, Bipolar Disorder (BPD) or Major Depressive Disorder (MDD) treated with Seroquel® or Seroquel®XR during the calendar periods: 13 Feb - 31 Aug 2012 seen by GP \& psychiatrists in Germany \& 11 Jan-31 July 2012 seen by GPs in the UK
Who cannot join
- Patients with above mentioned diagnoses treated with Seroquel® or Seroquel® XR/quetiapine fumarate not having any medical encounters during the time periods: 13 Feb - 31 Aug 2012 in Germany \& 11 Jan-31 July 2012 by GPs in the UK
About this study
Official title: Objective Assessment of Metabolic Monitoring in Patients Treated With Seroquel® or Seroquel® XR/Quetiapine Fumarate: Use of IMS Disease Analyzer to Assess Physician Behaviour in the UK and Germany
A study to evaluate the effectiveness of an update of educational materials with respect to evaluation of monitoring of metabolic parameters
Read the detailed description
Objective assessment of metabolic monitoring in patients treated with Seroquel® or Seroquel® XR/quetiapine fumarate: use of IMS Disease Analyzer to assess physician behaviour in the UK and Germany
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- Keywords
- Effectiveness of risk minimization, Metabolic monitoring, Seroquel® or Seroquel® XR/quetiapine fumarate
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major
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 |
|---|---|---|
| GER | All patients with a diagnosis of schizophrenia, bipolar disorder or major depressive disorder treated with Seroquel® or Seroquel® XR seen by general practitioners and psychiatrists in Germany based upon patient encounters recorded in IMS Disease Analyzer during the calendar period 13 February 2012 - 31 August 2012 | |
| UK | All patients with a diagnosis of schizophrenia, bipolar disorder or major depressive disorder treated with Seroquel® or Seroquel® XR seen by general practitioners in the United Kingdom based upon patient encounters recorded in IMS Disease Analyzer during the calendar period from 11 January 2012 - 31 July 2012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination whether physicians in the UK and Germany perform monitoring of patients treated with Seroquel® and Seroquel® XR including measurement of the following during patient encounters: weight at drug initiation and over the course of treatment.
Measured: Over 6 months following the distribution of metabolic educational materials in the country
Monitoring of hyperlipidemia during patient encounters.
Measured: Over 6 months following the distribution of metabolic educational materials in the country
Monitoring for signs and symptoms of hyperglycemia during patient encounters.
Measured: Over 6 months following the distribution of metabolic educational materials in the country
Monitoring of blood glucose in patients with diabetes; monitoring of patients with risk factors for diabetes for worsening of glycemic control during patient encounters.
Measured: Over 6 months following the distribution of metabolic educational materials in the country
Counseling patients on healthy eating, exercise and healthy lifestyle improvements during patient encounters.
Measured: Over 6 months following the distribution of metabolic educational materials in the country
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startApr 2012
- Primary completionJun 2013
- Study completionJun 2013
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
- Retrospective
- Enrolment
- 6,153 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert S Brody, MPH, Principal investigator, AZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793324
- Sponsor's protocol ID
- D1443C00128
- Status last verified
- Jan 2014
- First submitted
- 14 Feb 2013
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Metabolic Monitoring in Patients Treated With Seroquel® or Seroquel® XR/Quetiapine Fumarate: Use of IMS Disease Analyzer to Assess Physician Behaviour in the UK and Germany
- ClinicalTrials.gov ID
- NCT01793324
- Acronym / sponsor ID
- D1443C00128
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- Keywords
- Effectiveness of risk minimization, Metabolic monitoring, Seroquel® or Seroquel® XR/quetiapine fumarate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,153 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Feb 2013 (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.
A study to evaluate the effectiveness of an update of educational materials with respect to evaluation of monitoring of metabolic parameters
Detailed description
Objective assessment of metabolic monitoring in patients treated with Seroquel® or Seroquel® XR/quetiapine fumarate: use of IMS Disease Analyzer to assess physician behaviour in the UK and Germany
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GER | – | –All patients with a diagnosis of schizophrenia, bipolar disorder or major depressive disorder treated with Seroquel® or Seroquel® XR seen by general practitioners and psychiatrists in Germany based upon patient encounters recorded in IMS Disease Analyzer during the calendar period 13 February 2012 - 31 August 2012 |
| UK | – | –All patients with a diagnosis of schizophrenia, bipolar disorder or major depressive disorder treated with Seroquel® or Seroquel® XR seen by general practitioners in the United Kingdom based upon patient encounters recorded in IMS Disease Analyzer during the calendar period from 11 January 2012 - 31 July 2012 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cross sectional assessment of physician encounters with patients
Key inclusion criteria (1 listed)
- Electronic medical records of patients with diagnoses of schizophrenia, Bipolar Disorder (BPD) or Major Depressive Disorder (MDD) treated with Seroquel® or Seroquel®XR during the calendar periods: 13 Feb - 31 Aug 2012 seen by GP \& psychiatrists in Germany \& 11 Jan-31 July 2012 seen by GPs in the UK
Key exclusion criteria (1 listed)
- Patients with above mentioned diagnoses treated with Seroquel® or Seroquel® XR/quetiapine fumarate not having any medical encounters during the time periods: 13 Feb - 31 Aug 2012 in Germany \& 11 Jan-31 July 2012 by GPs in the UK
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
Determination whether physicians in the UK and Germany perform monitoring of patients treated with Seroquel® and Seroquel® XR including measurement of the following during patient encounters: weight at drug initiation and over the course of treatment.
Time frame: Over 6 months following the distribution of metabolic educational materials in the country
Monitoring of hyperlipidemia during patient encounters.
Time frame: Over 6 months following the distribution of metabolic educational materials in the country
Monitoring for signs and symptoms of hyperglycemia during patient encounters.
Time frame: Over 6 months following the distribution of metabolic educational materials in the country
Monitoring of blood glucose in patients with diabetes; monitoring of patients with risk factors for diabetes for worsening of glycemic control during patient encounters.
Time frame: Over 6 months following the distribution of metabolic educational materials in the country
Counseling patients on healthy eating, exercise and healthy lifestyle improvements during patient encounters.
Time frame: Over 6 months following the distribution of metabolic educational materials in the country
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 28 Jan 2014.
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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.
Robert S Brody, MPH principal investigator
AZ
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Bipolar Disorder, 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 1 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 28 Jan 2014. 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?
Determination whether physicians in the UK and Germany perform monitoring of patients treated with Seroquel® and Seroquel® XR including measurement of the following during patient encounters: weight at drug initiation and over the course of treatment. (time frame: Over 6 months following the distribution of metabolic educational materials in the country). The study lists 5 primary outcomes in all. 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 28 Jan 2014.