Comparing Hospitalisation Time With Seroquel and Seroquel ProlongNCT00965536
Nis Register Study Comparing Seroquel and Seroquel Prolong
An observational study of Comparing Hospitalisation Time With Seroquel and Seroquel Prolong, run by AstraZeneca at 1 site in Finland.
Trial summary
The general aim of this non interventional study is to clarify what are the current clinical treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release. The primary objectives of the study are:1.To collect information on the used Quetiapine Immediate Release or Quetiapine Extended Release… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Comparing Hospitalisation Time With Seroquel and Seroquel Prolong
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2009to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: South Karelia Central Hospital in-patients
Who may be able to join
- Medication: Seroquel or Seroquel Prolong
- Diagnosis: F20-F29 or F30-F31 (ICD-10)
- In-patient
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Local Non Interventional Retrospective Register Study of the Current Clinical Treatment Practices and the Number of Hospitalization Days With Seroquel or Seroquel Prolong.
The general aim of this non interventional study is to clarify what are the current clinical treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release. The primary objectives of the study are:1.To collect information on the used Quetiapine Immediate Release or Quetiapine Extended Release medication 2.To collect information on duration and number of hospitalisation days 3.Change of GAF points
- Keywords
- Schizophrenia, Bipolar Disorder, Manic Disorder, Register study, Quetiapine, Quetiapine Prolong, Seroquel, Seroquel Prolong, Seroquel XR, In-patient
- Medical subject headings
- Schizophrenia, 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 |
|---|---|---|
| 1 | Seroquel | |
| 2 | Seroquel Prolong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalisation time
Measured: 2008-2010
Treatment practice
Measured: 2008-2010
Secondary outcomes (3)
Primary diagnosis
Measured: 2008-2010
Medication at the end of hospitalisation
Measured: 2008-2010
GAF rating points
Measured: 2008-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparing Hospitalisation Time With Seroquel and Seroquel ProlongStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yrjö Ovaskainen, Study director, Medical Affairs Manager, MD, psychiatristKari Hänninen, Principal investigator, MD, psychiatrist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965536
- Sponsor's protocol ID
- NIS-NFI-SER-2009/1
- Status last verified
- Feb 2011
- First submitted
- 24 Aug 2009
- Last updated
- 16 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Local Non Interventional Retrospective Register Study of the Current Clinical Treatment Practices and the Number of Hospitalization Days With Seroquel or Seroquel Prolong.
- ClinicalTrials.gov ID
- NCT00965536
- Acronym / sponsor ID
- NIS-NFI-SER-2009/1
- Keywords
- Schizophrenia, Bipolar Disorder, Manic Disorder, Register study, Quetiapine, Quetiapine Prolong, Seroquel, Seroquel Prolong
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Aug 2009 (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 general aim of this non interventional study is to clarify what are the current clinical treatment practices of Quetiapine Immediate Release and Quetiapine Extended Release. The primary objectives of the study are:1.To collect information on the used Quetiapine Immediate Release or Quetiapine Extended Release medication 2.To collect information on duration and number of hospitalisation days 3.Change of GAF points
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Seroquel |
| 2 | – | –Seroquel Prolong |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- South Karelia Central Hospital in-patients
Key inclusion criteria (3 listed)
- Medication: Seroquel or Seroquel Prolong
- Diagnosis: F20-F29 or F30-F31 (ICD-10)
- In-patient
Key exclusion criteria (1 listed)
- None
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
Hospitalisation time
Time frame: 2008-2010
Treatment practice
Time frame: 2008-2010
3 secondary outcomes
Primary diagnosis
Time frame: 2008-2010
Medication at the end of hospitalisation
Time frame: 2008-2010
GAF rating points
Time frame: 2008-2010
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 16 Feb 2011.
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.
Yrjö Ovaskainen study director
Medical Affairs Manager, MD, psychiatrist
Kari Hänninen principal investigator
MD, psychiatrist
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 Comparing Hospitalisation Time With Seroquel and Seroquel Prolong, run by AstraZeneca at 1 site in Finland.
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 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 16 Feb 2011. 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 Finland. 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?
Hospitalisation time (time frame: 2008-2010). The study lists 2 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 16 Feb 2011.