SchizophreniaPHARMO IINCT01342120
PHARMO Institute Seroquel Safety Study
An observational study of Schizophrenia and Major Depressive Disorder, run by AstraZeneca.
Trial summary
The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Major Depressive Disorder, Bipolar Disorder
- How many people
- 18,325 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Nov 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: Population based sample of about 2.5 millions residents in the Netherlands
Who may be able to join
- Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics.
Who cannot join
- less than a year of recorded history before the cohort entry date
- use of multiple antipsychotics concomitantly
- duration and dose of the antipsychotic drug cannot be determined
About this study
Official title: Seroquel Safety Study
The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.
- Keywords
- atypical antipsychotics, quetiapine
- Medical subject headings
- Schizophrenia, Depressive Disorder, Major, Bipolar Disorder, Generalized Anxiety 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 | Quetipine users | |
| All other atypical antipsychotics | All other atypical antipsychotics users | |
| Risperidone | Risperidone users | |
| Olanzapine | Olanzapine users |
What is being measured
The primary outcome is the main question the study is designed to answer.
The outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startSep 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 18,325 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PHARMO Institute for Drug Outcomes Research
- Responsible party
- Sponsor
- Investigators
- Edith Heintjes, Principal investigator, PHARMO Institute for Drug Outcomes Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342120
- Sponsor's protocol ID
- D1443L00085
- Acronym
- PHARMO II
- Status last verified
- Aug 2011
- First submitted
- 21 Apr 2011
- Last updated
- 2 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Heintjes EM, Overbeek JA, Penning-van Beest FJ, Brobert G, Herings RM. Post authorization safety study comparing quetiapine to risperidone and olanzapine. Hum Psychopharmacol. 2016 Jul;31(4):304-12. doi: 10.1002/hup.2539. Epub 2016 Jun 13.
PubMed 27297785
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroquel Safety Study
- ClinicalTrials.gov ID
- NCT01342120
- Acronym / sponsor ID
- PHARMO II / D1443L00085
- Keywords
- atypical antipsychotics, quetiapine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,325 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- PHARMO Institute for Drug Outcomes Research
- Study start
- Sep 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 27 Apr 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 purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | – | –Quetipine users |
| All other atypical antipsychotics | – | –All other atypical antipsychotics users |
| Risperidone | – | –Risperidone users |
| Olanzapine | – | –Olanzapine users |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population based sample of about 2.5 millions residents in the Netherlands
Key inclusion criteria (1 listed)
- Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics.
Key exclusion criteria (3 listed)
- less than a year of recorded history before the cohort entry date
- use of multiple antipsychotics concomitantly
- 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 outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs
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 2 Sep 2011.
- Derived from this study: PubMed 27297785Heintjes EM, Overbeek JA, Penning-van Beest FJ, Brobert G, Herings RM. Post authorization safety study comparing quetiapine to risperidone and olanzapine. Hum Psychopharmacol. 2016 Jul;31(4):304-12. doi: 10.1002/hup.2539. Epub 2016 Jun 13.
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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.
Edith Heintjes principal investigator
PHARMO Institute for Drug Outcomes Research
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Major Depressive 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 3 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 2 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?
The outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01342120, which also lists 1 linked publication.
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 2 Sep 2011.