Acute Bipolar Manic EpisodeNCT01239589
European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes
An observational study of Acute Bipolar Manic Episode, run by AstraZeneca at 86 sites in 8 countries.
Trial summary
This study is being carried out to find out how patients suffering from the acute manic phase of bipolar disease are currently managed with Quetiapine Immediate Release (IR) or Quetiapine Extended Release (XR) in the hospital setting in real life practice, including length of stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bipolar Manic Episode
- How many people
- 1,280 participants
- Where
- 86 sitesin 8 countries
- Study dates
- Nov 2010to Mar 2011
- 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: Patients diagnosed with Bipolar Disorder (ICD-10).admitted due to a acute manic episode and treated with quetiapine IR or quetiapine XR during the hospitalization period
Who may be able to join
- Patients diagnosed with Bipolar Disorder (ICD-10).
- Admitted for acute bipolar manic episode from 1st October 2009 to 1st October 2010
- Patients treated with quetiapine IR or quetiapine XR during the hospitalization period.
Who cannot join
- Patients in which BD is not the main reason for hospitalization
- Patients admitted for acute bipolar mania episodes but finally diagnosed with mixed or bipolar disorder not otherwise specified (NOS) episodes
- Patients receiving both quetiapine IR and XR during the same hospitalization period.
Trial locations and contacts
86 sites in 8 countries.
86 sites in 8 countries
United Kingdom18 sites
Research Site
Bradford, Yorkshire
Research Site
Bury St Edmunds, Bury Saint Edmunds
Research Site
Cannock, Staffordshire
Research Site
Chertsey, Surrey
Research Site
Coventry, Coventry
Research Site
Dartford, Kent
Research Site
Ealing, London
Research Site
Hull, Hull
Research Site
Leeds, Leeds
Research Site
Leicester, Leicester
Research Site
London, London
Research Site
Newcastle upon Tyne, Newcastle (Upon Tyne)
Research Site
Norwich, Norfolk
Research Site
Prescot, Merseyside
Research Site
Pulborough, West Sussex
Research Site
Taunton, Somerset
Research Site
Winsford, Cheshire
Research Site
Wolverhampton, West Midlands
Italy17 sites
Research Site
Ascoli Piceno, Ascoli Piceno
Research Site
Bologna, Bologna
Research Site
Ceglie Messapica, Brindisi
Research Site
Conegliano, Treviso
Research Site
Cosenza, Cosenza
Research Site
Cuneo, Cuneo
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Ferrara, Ferrara
Research Site
Foggia, Foggia
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Lamezia Terme, Catanzaro
Research Site
Loc. S. Marciano (Sora), Frosinone
Research Site
Mestre, Mestre
Research Site
Pisa, Pisa
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Roma, Roma
Research Site
S. Agata Militello, Messina
Research Site
San Pietro Vernotico, Brindisi
Research Site
Sassari, Sassari
Research Site
Teramo, Teramo
Turkey (Türkiye)16 sites
Research Site
Adana, Adana
Research Site
Ankara, Ankara
Research Site
Aydin, Ayd?n
Research Site
Bolu, Bolu
Research Site
Diyarbakır, Diyarbakır
Research Site
Elâzığ, Elâzığ
Research Site
Erzurum, Erzurum
Research Site
Istanbul, Istanbul
Research Site
Kayseri, Kayseri
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Konya, Konya
Research Site
Manisa, Manisa
Research Site
Samsun, Samsun
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Sanliurfa, Şanlıurfa
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Sivas, Sivas
Research Site
Trabzon, Trabzon
Research Site
Zonguldak, Zonguldak Province
Belgium13 sites
Research Site
Assebroek, Belgium
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Bertrix, Belgium
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Bruges, Belgium
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Ghent, Belgium
Research Site
Godinne, Belgium
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Ixelles-Elsene, Belgium
Research Site
Koksijde, Belgium
Research Site
Malle, Belgium
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Marchienne-au-Pont, Belgium
Research Site
Montignies-sur-Sambre, Belgium
Research Site
Ottignies, Belgium
Research Site
Overpelt, Belgium
Research Site
Roeselaere, Belgium
Germany12 sites
Research Site
Berlin, State of Berlin
Research Site
Bielefeld, Lower Saxony
Research Site
Bochum, North Rhine-Westphalia
Research Site
Cham, Bavaria
Research Site
Greifswald, Mecklenburg-Vorpommern
Research Site
Hildesheim, Lower Saxony
Research Site
Liebenburg, Lower Saxony
Research Site
Neu�tting, Bavaria
Research Site
Regensburg, Bavaria
Research Site
Ulm, Baden-W�rttemberg
Research Site
Wasserburg am Inn, Bavaria
Research Site
W�rzburg, Bavaria
Denmark4 sites
Research Site
Augustenborg, Augustenborg
Research Site
Bispebjerg, Bispebjerg
Research Site
Br�nderslev, Br�nderslev
Research Site
Odense, Odense
Finland4 sites
Research Site
Ekenäs, Tammisaari
Research Site
Helsingin Kaupunki, Helsingin Kaupunki
Research Site
Jyv�skyl�, Jyv�skyl�
Research Site
Kellokoski, Kellokoski
About this study
Official title: European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes Treated With Immediate Release Quetiapine or Extended Release Quetiapine
This study is being carried out to find out how patients suffering from the acute manic phase of bipolar disease are currently managed with Quetiapine Immediate Release (IR) or Quetiapine Extended Release (XR) in the hospital setting in real life practice, including length of stay.
- Conditions
- Acute Bipolar Manic Episode
- Keywords
- Patients admitted as for an acute bipolar manic episode, Description of management patterns and hospital stay in patients admitted for acute bipolar manic episode and treated with either quetiapine IR or quetiapine XR
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 |
|---|---|---|
| 1 | patients admitted as for an acute bipolar manic episode and treated with quetiapine IR | |
| 2 | patients admitted as for an acute bipolar manic episode and treated with quetiapine XR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Secondary outcomes (3)
Use of resources
Treatments used
Demographics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2011
- Study completionMar 2011
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 Acute Bipolar Manic EpisodeStudies 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
- 1,280 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239589
- Sponsor's protocol ID
- NIS-NEU-SER-2010/1
- Status last verified
- Mar 2011
- First submitted
- 10 Nov 2010
- Last updated
- 29 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Karamustafalioglu O, Reif A, Atmaca M, Gonzalez D, Moreno-Manzanaro M, Gonzalez MA, Medina E, Bellomo A. Hospital stay in patients admitted for acute bipolar manic episodes prescribed quetiapine immediate or extended release: a retrospective non-interventional cohort study (HOME). BMC Psychiatry. 2014 Aug 31;14:246. doi: 10.1186/s12888-014-0246-3.
PubMed 25174996
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes Treated With Immediate Release Quetiapine or Extended Release Quetiapine
- ClinicalTrials.gov ID
- NCT01239589
- Acronym / sponsor ID
- NIS-NEU-SER-2010/1
- Conditions
- Acute Bipolar Manic Episode
- Keywords
- Patients admitted as for an acute bipolar manic episode, Description of management patterns and hospital stay in patients admitted for acute bipolar manic episode and treated with either quetiapine IR or quetiapine XR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,280 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 11 Nov 2010 (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.
This study is being carried out to find out how patients suffering from the acute manic phase of bipolar disease are currently managed with Quetiapine Immediate Release (IR) or Quetiapine Extended Release (XR) in the hospital setting in real life practice, including length of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients admitted as for an acute bipolar manic episode and treated with quetiapine IR |
| 2 | – | –patients admitted as for an acute bipolar manic episode and treated with quetiapine XR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Bipolar Disorder (ICD-10).admitted due to a acute manic episode and treated with quetiapine IR or quetiapine XR during the hospitalization period
Key inclusion criteria (3 listed)
- Patients diagnosed with Bipolar Disorder (ICD-10).
- Admitted for acute bipolar manic episode from 1st October 2009 to 1st October 2010
- Patients treated with quetiapine IR or quetiapine XR during the hospitalization period.
Key exclusion criteria (3 listed)
- Patients in which BD is not the main reason for hospitalization
- Patients admitted for acute bipolar mania episodes but finally diagnosed with mixed or bipolar disorder not otherwise specified (NOS) episodes
- Patients receiving both quetiapine IR and XR during the same hospitalization period.
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
Length of hospital stay
3 secondary outcomes
Use of resources
Treatments used
Demographics
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 29 Mar 2011.
- Derived from this study: PubMed 25174996Karamustafalioglu O, Reif A, Atmaca M, Gonzalez D, Moreno-Manzanaro M, Gonzalez MA, Medina E, Bellomo A. Hospital stay in patients admitted for acute bipolar manic episodes prescribed quetiapine immediate or extended release: a retrospective non-interventional cohort study (HOME). BMC Psychiatry. 2014 Aug 31;14:246. doi: 10.1186/s12888-014-0246-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
86 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Bipolar Manic Episode, run by AstraZeneca at 86 sites in 8 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 3 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 29 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in United Kingdom, Italy, Turkey (Türkiye), Belgium, Germany and 3 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.
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?
Length of hospital stay. 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 NCT01239589, 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 29 Mar 2011.