SchizophreniaSPINNCT01214135
A Retrospective Non-interventional Study to Evaluate the Use of Seroquel Extended Release (XR) and Immediate Release (IR) in the Clinical Practice of Inpatients With Schizophrenia
An observational study of Schizophrenia, run by AstraZeneca at 14 sites in Sweden.
Trial summary
The primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 300 participants
- Where
- 14 sitesSweden
- Study dates
- Oct 2010to 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 300 patients with schizophrenia who have been hospitalized during the study period (1st of July 2009 - 30th of September 2010).
Who may be able to join
- Diagnosis of schizophrenia.
- At least one dose of Seroquel XR or Seroquel IR during the study period (1st of July 2009 - 30th of September 2010).
- Hospitalization due to psychotic symptoms at any time during the study period (1st of July 2009 - 30th of September 2010) and with admission and discharge dates available.
Who cannot join
- Participation in a clinical trial during the study period.
- Treatment in forensic care according to LRV ("Lagen om Rättspsykiatrisk Vård").
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Sweden14 sites
Research Site
Falköping
Research Site
Gothenburg
Research Site
Helsingborg
Research Site
Karlskrona
Research Site
Karlstad
Research Site
Lund
Research Site
Malmö
Research Site
Mölndal
Research Site
Öjebyn
Research Site
Stockholm
Research Site
Trollhättan
Research Site
Umeå
Research Site
Uppsala
Research Site
Vaxjo
About this study
Official title: A Retrospective, Non-interventional Study to Evaluate the Use of Seroquel XR and Seroquel IR in the Clinical Practice of Inpatients With Schizophrenia
The primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary antipsychotic treatment.
- Conditions
- Schizophrenia
- Keywords
- Mental disorder, antipsychotic treatment
- Medical subject headings
- Schizophrenia, Mental Disorders
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 with a diagnosis of schizophrenia who have been hospitalized and received at least one dose of Seroquel XR or Seroquel IR during the study period (1st of July 2009 - 30th of September 2010). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia
Measured: every day for the time period of 15 Oct to 31 Dec 2010
Secondary outcomes (3)
To investigate comorbidities of patients with schizophrenia receiving Seroquel XR and IR
Measured: every day for the time period of 15 Oct to 31 Dec 2010
To investigate whether Seroquel XR and Seroquel IR are used to treat different types of inpatients with schizophrenia by evaluation of patient characteristics
Measured: every day for the time period of 15 Oct to 31 Dec 2010
To investigate the treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR
Measured: every day for the time period of 15 Oct to 31 Dec 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr Eva Dencker Vansvik, MD, Study director, AstraZenecaDr Lars Eriksson, MD, Principal investigator, Rättspsykiatriska Vårdkedjan, Hisings-Backa, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01214135
- Sponsor's protocol ID
- NIS-NSE-SER-2010/1
- Acronym
- SPIN
- Status last verified
- Jan 2011
- First submitted
- 24 Sep 2010
- Last updated
- 11 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Eriksson L, Hallerback T, Jorgensen L, Carlborg A. Use of quetiapine XR and quetiapine IR in clinical practice for hospitalized patients with schizophrenia: a retrospective study. Ther Adv Psychopharmacol. 2012 Dec;2(6):217-26. doi: 10.1177/2045125312453935.
PubMed 23983980
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Non-interventional Study to Evaluate the Use of Seroquel XR and Seroquel IR in the Clinical Practice of Inpatients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01214135
- Acronym / sponsor ID
- SPIN / NIS-NSE-SER-2010/1
- Conditions
- Schizophrenia
- Keywords
- Mental disorder, antipsychotic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 4 Oct 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.
The primary objective of this non-interventional study is to investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia. This will be done by a retrospective review of medical records to evaluate patients treated with Seroquel XR or Seroquel IR as primary antipsychotic treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with a diagnosis of schizophrenia who have been hospitalized and received at least one dose of Seroquel XR or Seroquel IR during the study period (1st of July 2009 - 30th of September 2010). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 300 patients with schizophrenia who have been hospitalized during the study period (1st of July 2009 - 30th of September 2010).
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia.
- At least one dose of Seroquel XR or Seroquel IR during the study period (1st of July 2009 - 30th of September 2010).
- Hospitalization due to psychotic symptoms at any time during the study period (1st of July 2009 - 30th of September 2010) and with admission and discharge dates available.
Key exclusion criteria (2 listed)
- Participation in a clinical trial during the study period.
- Treatment in forensic care according to LRV ("Lagen om Rättspsykiatrisk Vård").
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
To investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia
Time frame: every day for the time period of 15 Oct to 31 Dec 2010
3 secondary outcomes
To investigate comorbidities of patients with schizophrenia receiving Seroquel XR and IR
Time frame: every day for the time period of 15 Oct to 31 Dec 2010
To investigate whether Seroquel XR and Seroquel IR are used to treat different types of inpatients with schizophrenia by evaluation of patient characteristics
Time frame: every day for the time period of 15 Oct to 31 Dec 2010
To investigate the treatment sequence of Seroquel XR and Seroquel IR in the clinical practice of patients with schizophrenia by evaluation of duration, dosage, reason for treatment, and, if applicable, reason for change, with Seroquel XR and Seroquel IR
Time frame: every day for the time period of 15 Oct to 31 Dec 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 11 Jan 2011.
- Derived from this study: PubMed 23983980Eriksson L, Hallerback T, Jorgensen L, Carlborg A. Use of quetiapine XR and quetiapine IR in clinical practice for hospitalized patients with schizophrenia: a retrospective study. Ther Adv Psychopharmacol. 2012 Dec;2(6):217-26. doi: 10.1177/2045125312453935.
Related trials for Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
RecruitingObservational study
Sensory Profile and Early Clinical Signs of Calm Room Users
Psychotic Disorders, Personality Disorders
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.
Dr Eva Dencker Vansvik, MD study director
AstraZeneca
Dr Lars Eriksson, MD principal investigator
Rättspsykiatriska Vårdkedjan, Hisings-Backa, Sweden
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by AstraZeneca at 14 sites in Sweden.
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 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 11 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Sweden. 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?
To investigate how Seroquel XR and Seroquel IR are used in the clinical practice of inpatients with schizophrenia (time frame: every day for the time period of 15 Oct to 31 Dec 2010). 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 NCT01214135, 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 11 Jan 2011.