Bipolar DisorderNCT01498770
An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308)
An observational study of Bipolar Disorder, run by Organon and Co.
Trial summary
This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK) during the post-approval period under conditions of usual practice. The use of asenapine in Bipolar Disorder and other indications will be described. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Asenapine, Aripiprazole and Quetiapine
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 21 Dec 2017
- 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: The study population is drawn from UK general practitioner practices participating in CPRD. The database is generally representative of the UK general population.
Who may be able to join
- At least 1 prescription for asenapine within the study period
- Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date
- A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for asenapine
- Inclusion Criteria for Participants Treated with a Comparator:
- Age 18 years or greater at the time participant receives a prescription for the comparator
- At least 1 prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine within the study period
- Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date
- A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine
Who cannot join
- None
About this study
Official title: An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom
This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK) during the post-approval period under conditions of usual practice. The use of asenapine in Bipolar Disorder and other indications will be described. To provide epidemiological and clinical perspective, use of aripiprazole and other comparator drugs will be described.
Read the detailed description
The data source for this study will be the Clinical Practice Research Database (CPRD) in the UK. New users of asenapine during the period following the UK marketing launch of asenapine will be identified in the CPRD. Use in Bipolar Disorder and other indications, as well as baseline demographic and physical characteristics, including prior health status, comorbidities, concomitant medications and healthcare resource utilization, will be described for the asenapine cohort, for participants aged 18 or greater. Use of asenapine in the general practice setting among pediatric participants will be described.
The primary comparison cohort will be aripiprazole. Participants in the aripiprazole cohort will be matched to participants treated with asenapine based on respective time after market entry. In addition, non-matched cohorts will be used to describe utilization of aripiprazole and other comparators.
- Conditions
- Bipolar Disorder
- Being tested
- Asenapine, Aripiprazole, Quetiapine, Risperidone, Olanzapine
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AsenapineDrug
Also called Sycrest, SCH 900274
Asenapine prescribed as recorded in the CPRD in the UK
AripiprazoleDrug
Also called Abilfy
Aripiprazole prescribed as recorded in the CPRD in the UK
QuetiapineDrug
Also called Seroquel
Quetiapine prescribed as recorded in the CPRD in the UK
RisperidoneDrug
Also called Risperdal
Risperidone prescribed as recorded in the CPRD in the UK
OlanzapineDrug
Also called Zyprexa
Olanzapine prescribed as recorded in the CPRD in the UK
ZiprasidoneDrug
Ziprasidone prescribed as recorded in the CPRD in the UK
IloperidoneDrug
Iloperidone prescribed as recorded in the CPRD in the UK
PaliperidoneDrug
Paliperidone prescribed as recorded in the CPRD in the UK
LurasidoneDrug
Lurasidone prescribed as recorded in the CPRD in the UK
ClozapineDrug
Clozapine prescribed as recorded in the CPRD in the UK
AmisulprideDrug
Amisulpride prescribed as recorded in the CPRD in the UK
SertindoleDrug
Sertindole prescribed as recorded in the CPRD in the UK
ZotepineDrug
Zotepine prescribed as recorded in the CPRD in the UK
| Study group | Role | What they receive |
|---|---|---|
| Asenapine | Not described Receives: Drug: Asenapine | |
| Aripiprazole | Not described Receives: Drug: Aripiprazole | |
| Quetiapine | Not described Receives: Drug: Quetiapine | |
| Risperidone | Not described Receives: Drug: Risperidone | |
| Olanzapine | Not described Receives: Drug: Olanzapine | |
| Ziprasidone | Not described Receives: Drug: Ziprasidone | |
| Iloperidone | Not described Receives: Drug: Iloperidone | |
| Paliperidone | Not described Receives: Drug: Paliperidone | |
| Lurasidone | Not described Receives: Drug: Lurasidone | |
| Clozapine | Not described Receives: Drug: Clozapine | |
| Amisulpride | Not described Receives: Drug: Amisulpride | |
| Sertindole | Not described Receives: Drug: Sertindole | |
| Zotepine | Not described Receives: Drug: Zotepine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater
Measured: From baseline through 730 days after date of prescription
Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with Schizophrenia and No Diagnosis of Bipolar Disorder
Measured: From baseline through 730 days after date of prescription
Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with No Diagnosis of Bipolar Disorder or Schizophrenia, by Other Diagnosis
Measured: From baseline through 730 days after date of prescription
Baseline Age of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK
Measured: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Gender of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK
Measured: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis
Measured: From baseline through 365 days after date of prescription
Baseline Age of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK
Measured: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Gender of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK
Measured: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study start1 Apr 2013
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498770
- Sponsor's protocol ID
- P08308
- Other IDs
- MK-8274-108
- Status last verified
- Feb 2022
- First submitted
- 21 Dec 2011
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom
- ClinicalTrials.gov ID
- NCT01498770
- Acronym / sponsor ID
- P08308
- Conditions
- Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 23 Dec 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.
This study is designed to describe asenapine prescribing patterns in the United Kingdom (UK) during the post-approval period under conditions of usual practice. The use of asenapine in Bipolar Disorder and other indications will be described. To provide epidemiological and clinical perspective, use of aripiprazole and other comparator drugs will be described.
Detailed description
The data source for this study will be the Clinical Practice Research Database (CPRD) in the UK. New users of asenapine during the period following the UK marketing launch of asenapine will be identified in the CPRD. Use in Bipolar Disorder and other indications, as well as baseline demographic and physical characteristics, including prior health status, comorbidities, concomitant medications and healthcare resource utilization, will be described for the asenapine cohort, for participants aged 18 or greater. Use of asenapine in the general practice setting among pediatric participants will be described.
The primary comparison cohort will be aripiprazole. Participants in the aripiprazole cohort will be matched to participants treated with asenapine based on respective time after market entry. In addition, non-matched cohorts will be used to describe utilization of aripiprazole and other comparators.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Asenapine | – | Drug: Asenapine |
| Aripiprazole | – | Drug: Aripiprazole |
| Quetiapine | – | Drug: Quetiapine |
| Risperidone | – | Drug: Risperidone |
| Olanzapine | – | Drug: Olanzapine |
| Ziprasidone | – | Drug: Ziprasidone |
| Iloperidone | – | Drug: Iloperidone |
| Paliperidone | – | Drug: Paliperidone |
| Lurasidone | – | Drug: Lurasidone |
| Clozapine | – | Drug: Clozapine |
| Amisulpride | – | Drug: Amisulpride |
| Sertindole | – | Drug: Sertindole |
| Zotepine | – | Drug: Zotepine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is drawn from UK general practitioner practices participating in CPRD. The database is generally representative of the UK general population.
Key inclusion criteria (8 listed)
- At least 1 prescription for asenapine within the study period
- Date of prescription occurs after the CPRD subject registration date or the database specific quality indicator date
- A minimum of 365 or more days of evaluable baseline observation time, occurring prior to the date of prescription for asenapine
- Age 18 years or greater at the time participant receives a prescription for the comparator
- At least 1 prescription for either aripiprazole, quetiapine, risperidone, olanzapine, ziprasidone, iloperidone, paliperidone, lurasidone, clozapine, amisulpride, sertindole or zotepine within the study period
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AsenapineAlso: Sycrest, SCH 900274Asenapine prescribed as recorded in the CPRD in the UK | Drug | Asenapine |
| AripiprazoleAlso: AbilfyAripiprazole prescribed as recorded in the CPRD in the UK | Drug | Aripiprazole |
| QuetiapineAlso: SeroquelQuetiapine prescribed as recorded in the CPRD in the UK | Drug | Quetiapine |
| RisperidoneAlso: RisperdalRisperidone prescribed as recorded in the CPRD in the UK | Drug | Risperidone |
| OlanzapineAlso: ZyprexaOlanzapine prescribed as recorded in the CPRD in the UK | Drug | Olanzapine |
| ZiprasidoneZiprasidone prescribed as recorded in the CPRD in the UK | Drug | Ziprasidone |
| IloperidoneIloperidone prescribed as recorded in the CPRD in the UK | Drug | Iloperidone |
| PaliperidonePaliperidone prescribed as recorded in the CPRD in the UK | Drug | Paliperidone |
| LurasidoneLurasidone prescribed as recorded in the CPRD in the UK | Drug | Lurasidone |
| ClozapineClozapine prescribed as recorded in the CPRD in the UK | Drug | Clozapine |
| AmisulprideAmisulpride prescribed as recorded in the CPRD in the UK | Drug | Amisulpride |
| SertindoleSertindole prescribed as recorded in the CPRD in the UK | Drug | Sertindole |
| ZotepineZotepine prescribed as recorded in the CPRD in the UK | Drug | Zotepine |
Primary outcome
Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater
Time frame: From baseline through 730 days after date of prescription
Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with Schizophrenia and No Diagnosis of Bipolar Disorder
Time frame: From baseline through 730 days after date of prescription
Frequency and Proportion of Use Among Asenapine and Aripiprazole Participants Aged 18 or Greater with No Diagnosis of Bipolar Disorder or Schizophrenia, by Other Diagnosis
Time frame: From baseline through 730 days after date of prescription
Baseline Age of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK
Time frame: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Gender of Asenapine Participants Aged 18 or Greater Initiating Asenapine During the First Year Since Drug Product Marketing in UK
Time frame: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis
Time frame: From baseline through 365 days after date of prescription
Baseline Age of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK
Time frame: Baseline observation period (minimum of at least 365 days prior to date of prescription)
Gender of Asenapine Participants Less Than 18 Years Old Initiating Asenapine During the First Year Since Drug Product Marketing in UK
Time frame: Baseline observation period (minimum of at least 365 days prior to date of prescription)
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 Feb 2022.
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Organon and Co.
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 8 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 4 Feb 2022. 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?
Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater (time frame: From baseline through 730 days after date of prescription). The study lists 8 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 4 Feb 2022.