SchizophreniaGPRD SeroquelSNCT01447082
General Practice Research Database Seroquel XR Safety Study
An observational study of Schizophrenia and Major Depressive Disorder, run by AstraZeneca at 1 site in Switzerland.
Trial summary
The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Schizophrenia, Major Depressive Disorder, Bipolar Disorder
- How many people
- 37,372 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2008to Dec 2012
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A sample of the general population in the UK consisting of 3 millions inhabitants.
Who may be able to join
- Episodes of new use (>/=1 prescription) of quetiapine XR or other study drugs
Who cannot join
- Less than two years of recorded history before the start of the marketing of quetiapine XR (or cohort entry date)
- If the duration and dose of the antipsychotic drug cannot be determined
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology Study to Assess the Safety of a New Slow-release Form of Seroquel (Quetiapine) in the Post-marketing Phase in the UK
The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs.
Read the detailed description
Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine) in the post-marketing phase in the UK.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar Disorder
- Keywords
- atypical, antipsychotics, quetiapine
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major, Bipolar Disorder
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 |
|---|---|---|
| Quetiapine XR group | Not described | |
| Non-quetiapine comparison group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugs
Measured: During follow-up of a treatment episode estimated to be on average of 1.5 years
Duration of treatment
Measured: During follow-up estimated to be on average of 1.5 years.
Duration of treatment episode
Episode, defined as the treatment time from first to last prescription of quetiapine XR or other study drugs.
Measured: During follow-up estimated to be on average of 1.5 years
Comorbidities defined by clinical diagnosis or prescription
Measured: Baseline and during follow up of treatment estimated to be on average 1.5 years
Age
Measured: Baseline
Gender
Measured: Baseline
Dose
Measured: During follow-up of treatment estimated to be on average 1.5 years
Adherence
Measured: During follow-up of treatment estimated to be on average 1.5 years
The number of subjects to whom the drug was prescribed by the general practitioners.
The number of patients, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner or another type of physician).
Measured: During follow-up of treatment estimated to be on average 1.5 years
Indication for treatment
Measured: During follow-up of treatment estimated to be on averaged 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2008
- Primary completionDec 2012
- Study completionDec 2012
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
- 37,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Basel, Switzerland
- Responsible party
- Sponsor
- Investigators
- Christoph R Meier, PROF DR PHIL, Principal investigator, University hospital of Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447082
- Sponsor's protocol ID
- D1444C00006
- Acronym
- GPRD SeroquelS
- Status last verified
- Feb 2014
- First submitted
- 19 Sep 2011
- Last updated
- 7 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology Study to Assess the Safety of a New Slow-release Form of Seroquel (Quetiapine) in the Post-marketing Phase in the UK
- ClinicalTrials.gov ID
- NCT01447082
- Acronym / sponsor ID
- GPRD SeroquelS / D1444C00006
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar Disorder
- Keywords
- atypical, antipsychotics, quetiapine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,372 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Basel, Switzerland
- Study start
- Oct 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Oct 2011 (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.
The main objective of this observational study is to characterize new users of quetiapine XR as well as new users of other study drugs (i.e. the comparison group) and to quantify the risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well as in other study drugs.
Detailed description
Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine) in the post-marketing phase in the UK.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine XR group | – | – |
| Non-quetiapine comparison group | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A sample of the general population in the UK consisting of 3 millions inhabitants.
Key inclusion criteria (1 listed)
- Episodes of new use (>/=1 prescription) of quetiapine XR or other study drugs
Key exclusion criteria (2 listed)
- Less than two years of recorded history before the start of the marketing of quetiapine XR (or cohort entry date)
- If the duration and dose of the antipsychotic drug cannot be determined
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
The outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugs
Time frame: During follow-up of a treatment episode estimated to be on average of 1.5 years
Duration of treatment
Time frame: During follow-up estimated to be on average of 1.5 years.
Duration of treatment episode
Time frame: During follow-up estimated to be on average of 1.5 years
Episode, defined as the treatment time from first to last prescription of quetiapine XR or other study drugs.
Comorbidities defined by clinical diagnosis or prescription
Time frame: Baseline and during follow up of treatment estimated to be on average 1.5 years
Age
Time frame: Baseline
Gender
Time frame: Baseline
Dose
Time frame: During follow-up of treatment estimated to be on average 1.5 years
Adherence
Time frame: During follow-up of treatment estimated to be on average 1.5 years
The number of subjects to whom the drug was prescribed by the general practitioners.
Time frame: During follow-up of treatment estimated to be on average 1.5 years
The number of patients, whom the drug was prescribed by the specified type of prescriber (specialist, general practitioner or another type of physician).
Indication for treatment
Time frame: During follow-up of treatment estimated to be on averaged 1.5 years
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 7 Feb 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.
Christoph R Meier, PROF DR PHIL principal investigator
University hospital of Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Major Depressive Disorder, run by AstraZeneca at 1 site in Switzerland.
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 7 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The outcome of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine XR vs corresponding incidence rates in users of comparison drugs (time frame: During follow-up of a treatment episode estimated to be on average of 1.5 years). The study lists 10 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 7 Feb 2014.