SchizophreniaNCT01795326
Physician Survey on Monitoring of Patients Treated With Quetiapine
An observational study of Schizophrenia and Bipolar Disorder, run by AstraZeneca.
Trial summary
A physician survey to document receipt of metabolic educational materials and assess behavior of physicians in following messages communicated through the educational materials Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR.
Who may be able to join
- Physicians targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR.
Who cannot join
- Physicians who have participated in a survey involving SEROQUEL® / SEROQUEL® XR in the past six months are not eligible to participate in this survey.
About this study
Official title: Assessment of Physician Behavior Regarding Metabolic Monitoring of Patients Treated With SEROQUEL® (Quetiapine Fumarate) Tablets and SEROQUEL® (Quetiapine Fumarate) Extended Release Tablets in Selected Countries in the EU
A physician survey to document receipt of metabolic educational materials and assess behavior of physicians in following messages communicated through the educational materials
Read the detailed description
Assessment of physician behavior regarding metabolic monitoring of patients treated with SEROQUEL® (quetiapine fumarate) Tablets and SEROQUEL® (quetiapine fumarate) Extended Release Tablets in selected countries in the EU
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- Keywords
- Effectiveness of risk minimization, Metabolic monitoring, Seroquel®, 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 |
|---|---|---|
| Germany | A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. | |
| United Kingdom | A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. | |
| Spain | A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. | |
| Hungary | A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. | |
| Netherlands | A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. | |
| Sweden | A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. | |
| Romania | A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. | |
| Italy | A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination via survey whether physicians or someone in their practice perform monitoring of patients treated with Seroquel or Seroquel XR for metabolic issues related to treatment; refer their patients to another physician for monitoring.
Measured: Over 6- 8 weeks.
Determination via survey whether physicians monitor tests for hyperlipidemia in patients who are taking Seroquel or Seroquel XR.
Measured: Over 6- 8 weeks.
Determination via survey whether physicians monitor for signs and symptoms of hyperglycemia in patients who are taking Seroquel or Seroquel XR.
Measured: Over 6- 8 weeks.
Determination via survey whether physicians monitor blood glucose in patients with diabetes or monitor patients with risk factors for diabetes for worsening of glycemic control if they are taking Seroquel or Seroquel XR.
Measured: Over 6- 8 weeks.
Determination via survey whether physicians monitor weight at initiation of treatment with Seroquel or Seoquel XR and on a regular basis after initiating treatment.
Measured: Over 6- 8 weeks.
Secondary outcomes (3)
Determination via survey whether physicians counsel patients taking with Seroquel or Seroquel XR on healthy eating, exercise, and healthy lifestyle improvements.
Measured: Over 6- 8 weeks.
Determination via survey whether physicians received educational information relevant to the issues in the survey from AstraZeneca.
Measured: Over 6- 8 weeks.
Determination via survey whether physicians read the educational information.
Measured: Over 6- 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startJun 2013
- Primary completionSep 2013
- Study completionSep 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
- Cross-sectional
- Enrolment
- 800 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
- NCT01795326
- Sponsor's protocol ID
- D1443C00127
- Status last verified
- Jan 2014
- First submitted
- 18 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
- Assessment of Physician Behavior Regarding Metabolic Monitoring of Patients Treated With SEROQUEL® (Quetiapine Fumarate) Tablets and SEROQUEL® (Quetiapine Fumarate) Extended Release Tablets in Selected Countries in the EU
- ClinicalTrials.gov ID
- NCT01795326
- Acronym / sponsor ID
- D1443C00127
- Conditions
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- Keywords
- Effectiveness of risk minimization, Metabolic monitoring, Seroquel®, Seroquel® XR/quetiapine fumarate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 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 physician survey to document receipt of metabolic educational materials and assess behavior of physicians in following messages communicated through the educational materials
Detailed description
Assessment of physician behavior regarding metabolic monitoring of patients treated with SEROQUEL® (quetiapine fumarate) Tablets and SEROQUEL® (quetiapine fumarate) Extended Release Tablets in selected countries in the EU
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Germany | – | –A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. |
| United Kingdom | – | –A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. |
| Spain | – | –A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. |
| Hungary | – | –A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. |
| Netherlands | – | –A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. |
| Sweden | – | –A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. |
| Romania | – | –A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. |
| Italy | – | –A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A sample of physicians who were targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR.
Key inclusion criteria (1 listed)
- Physicians targeted to receive the metabolic educational materials and either currently prescribe or have the potential to prescribe SEROQUEL® or SEROQUEL® XR.
Key exclusion criteria (1 listed)
- Physicians who have participated in a survey involving SEROQUEL® / SEROQUEL® XR in the past six months are not eligible to participate in this survey.
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 via survey whether physicians or someone in their practice perform monitoring of patients treated with Seroquel or Seroquel XR for metabolic issues related to treatment; refer their patients to another physician for monitoring.
Time frame: Over 6- 8 weeks.
Determination via survey whether physicians monitor tests for hyperlipidemia in patients who are taking Seroquel or Seroquel XR.
Time frame: Over 6- 8 weeks.
Determination via survey whether physicians monitor for signs and symptoms of hyperglycemia in patients who are taking Seroquel or Seroquel XR.
Time frame: Over 6- 8 weeks.
Determination via survey whether physicians monitor blood glucose in patients with diabetes or monitor patients with risk factors for diabetes for worsening of glycemic control if they are taking Seroquel or Seroquel XR.
Time frame: Over 6- 8 weeks.
Determination via survey whether physicians monitor weight at initiation of treatment with Seroquel or Seoquel XR and on a regular basis after initiating treatment.
Time frame: Over 6- 8 weeks.
3 secondary outcomes
Determination via survey whether physicians counsel patients taking with Seroquel or Seroquel XR on healthy eating, exercise, and healthy lifestyle improvements.
Time frame: Over 6- 8 weeks.
Determination via survey whether physicians received educational information relevant to the issues in the survey from AstraZeneca.
Time frame: Over 6- 8 weeks.
Determination via survey whether physicians read the educational information.
Time frame: Over 6- 8 weeks.
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 via survey whether physicians or someone in their practice perform monitoring of patients treated with Seroquel or Seroquel XR for metabolic issues related to treatment; refer their patients to another physician for monitoring. (time frame: Over 6- 8 weeks.). 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; AzTrials last refreshed its copy on 8 Nov 2026.