SchizophreniaPhase 4NCT00214578
Seroquel on Glucose Metabolism
A Phase 4 study testing Seroquel (quetiapine) in people with Schizophrenia, run by AstraZeneca at 70 sites in 9 countries.
Trial summary
The purpose of this study is to determine whether six months treatment with the antipsychotic medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Seroquel (quetiapine)
- How many people
- 572 participants
- Where
- 70 sitesin 9 countries
- Study dates
- Apr 2004to Oct 2005
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.
Who cannot join
- Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT.
- Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
- Contraindications or non-responsiveness for any of the treatments or other safety issues
- Expected non-compliance to treatment and/or study procedures
Trial locations and contacts
70 sites in 9 countries.
70 sites in 9 countries
Germany13 sites
Research Site
Berlin
Research Site
Bonn, North Rhine-Westphalia
Research Site
Bonn
Research Site
Düsseldorf, North Rhine-Westphalia
Research Site
Düsseldorf
Research Site
Herten
Research Site
Magdeburg, Saxony-Anhalt
Research Site
Magdeburg
Research Site
München, Bavaria
Research Site
München
Research Site
Münster, North Rhine-Westphalia
Research Site
Tübingen, Baden-Wurttemberg
Research Site
Tübingen
Slovakia12 sites
Research Site
¿ilina
Research Site
¿ilina-Byt¿ica
Research Site
Banská Bystrica
Research Site
Bojnice
Research Site
Bratislava
Research Site
Domaša
Research Site
Ko¿ice
Research Site
Liptovský Mikulá¿
Research Site
Michalovce Strá¿any
Research Site
Nitra
Research Site
Pre¿ov
Research Site
Rimavská Sobota
Hungary10 sites
Research Site
Balassagyarmat
Research Site
Budapest
Research Site
Cegléd
Research Site
Debrecen
Research Site
Eger
Research Site
Gy¿r
Research Site
Kaposvár
Research Site
Kecskemét
Research Site
Szeged
Research Site
Szolnok
South Africa10 sites
Research Site
Bloemfontein
Research Site
CapeTown
Research Site
Durban
Research Site
Ga-Rankuwa
Research Site
Johannesburg
Research Site
Krugersdorp
Research Site
Medunsa, Pretoria
Research Site
Parktown
Research Site
Pretoria
Research Site
Tygerberg
Czechia8 sites
Research Site
Dob¿any U Plzn¿
Research Site
Dobjany
Research Site
Havlí¿k¿v Brod
Research Site
Kladno
Research Site
Miro¿ov
Research Site
Opava
Research Site
Pilsen
Research Site
Prague
Norway7 sites
Research Site
Bergen
Research Site
Drammen
Research Site
Hagavik
Research Site
Stavanger
Research Site
Stokmarknes
Research Site
Straume
Research Site
Tønsberg
Bulgaria5 sites
Research Site
Burgas
Research Site
Rousse
Research Site
Sofia
Research Site
Sofia- Novi Iskar
Research Site
Varna
United Kingdom2 sites
Research Site
Birmingham
Research Site
Sutton Coldfield, West Midlands
About this study
The purpose of this study is to determine whether six months treatment with the antipsychotic medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism
- Conditions
- Schizophrenia
- Being tested
- Seroquel (quetiapine)
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seroquel (quetiapine)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
Secondary outcomes (1)
Glucose metabolism, blood lipid levels and weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2004
- Study completionOct 2005
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 572 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca CNS Medical Group, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214578
- Sponsor's protocol ID
- D1441C00125
- Status last verified
- Jan 2013
- First submitted
- 14 Sep 2005
- Last updated
- 4 Jan 2013
- Results posted
- No
Publications
Newcomer JW, Ratner RE, Eriksson JW, Emsley R, Meulien D, Miller F, Leonova-Edlund J, Leong RW, Brecher M. A 24-week, multicenter, open-label, randomized study to compare changes in glucose metabolism in patients with schizophrenia receiving treatment with olanzapine, quetiapine, or risperidone. J Clin Psychiatry. 2009 Apr;70(4):487-99. doi: 10.4088/jcp.08m04132. Epub 2009 Apr 7.
PubMed 19358783
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroquel on Glucose Metabolism
- ClinicalTrials.gov ID
- NCT00214578
- Acronym / sponsor ID
- D1441C00125
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 572 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Oct 2005 (actual)
- First posted
- 22 Sep 2005 (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 study is to determine whether six months treatment with the antipsychotic medicine Seroquel (quetiapine) may affect the schizophrenic patient's glucose metabolism
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In- or outpatients with schizophrenia, 18-65 years old, requiring a change in treatment due to insufficient efficacy or tolerability and giving signed informed consent.
Key exclusion criteria (4 listed)
- Known diabetes mellitus, high HbA1c, fasting plasma glucose and/or high 2h glucose-OGTT.
- Previous use of atypicals (3 months) or other medications that might influence glucose metabolism
- Contraindications or non-responsiveness for any of the treatments or other safety issues
- Expected non-compliance to treatment and/or study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seroquel (quetiapine) | Drug | – |
Primary outcome
To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients
1 secondary outcome
Glucose metabolism, blood lipid levels and weight
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 4 Jan 2013.
- Derived from this study: PubMed 19358783Newcomer JW, Ratner RE, Eriksson JW, Emsley R, Meulien D, Miller F, Leonova-Edlund J, Leong RW, Brecher M. A 24-week, multicenter, open-label, randomized study to compare changes in glucose metabolism in patients with schizophrenia receiving treatment with olanzapine, quetiapine, or risperidone. J Clin Psychiatry. 2009 Apr;70(4):487-99. doi: 10.4088/jcp.08m04132. Epub 2009 Apr 7.
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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.
AstraZeneca CNS Medical Group study director
AstraZeneca
70 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Seroquel (quetiapine) in people with Schizophrenia, run by AstraZeneca at 70 sites in 9 countries.
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 4 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 4 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in Germany, Slovakia, Hungary, South Africa, Czechia and 4 more countries. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To analyze the safety/tolerability profile of quetiapine on glucose metabolism in schizophrenic patients. 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 NCT00214578, 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 4 Jan 2013.