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| ID | Type | Description | Link |
|---|---|---|---|
| MK-8274-108 | Other Identifier | Merck |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asenapine |
| ||
| Aripiprazole |
| ||
| Quetiapine |
| ||
| Risperidone |
| ||
| Olanzapine |
| ||
| Ziprasidone |
| ||
| Iloperidone |
| ||
| Paliperidone |
| ||
| Lurasidone |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asenapine | Drug | Asenapine prescribed as recorded in the CPRD in the UK |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and Proportion of Use, by Psychiatric Diagnosis, Among Asenapine and Aripiprazole Participants Aged 18 or Greater | 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 | 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 | 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 | 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 | Baseline observation period (minimum of at least 365 days prior to date of prescription) | |
| Frequency and Proportion of Pediatric Use, by Psychiatric Diagnosis | 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 | 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 |
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Inclusion Criteria for Participants Treated with Asenapine:
Inclusion Criteria for Participants Treated with a Comparator:
Exclusion Criteria:
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The study population is drawn from UK general practitioner practices participating in CPRD. The database is generally representative of the UK general population.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C522667 | asenapine |
| D000068180 | Aripiprazole |
| D000069348 | Quetiapine Fumarate |
| D018967 | Risperidone |
| D000077152 | Olanzapine |
| C092292 | ziprasidone |
| C081732 | iloperidone |
| D000068882 | Paliperidone Palmitate |
| D000069056 | Lurasidone Hydrochloride |
| D003024 | Clozapine |
| D000077582 | Amisulpride |
| C066304 | sertindole |
| C022172 | zotepine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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|
| Clozapine |
|
| Amisulpride |
|
| Sertindole |
|
| Zotepine |
|
| Aripiprazole | Drug | Aripiprazole prescribed as recorded in the CPRD in the UK |
|
|
| Quetiapine | Drug | Quetiapine prescribed as recorded in the CPRD in the UK |
|
|
| Risperidone | Drug | Risperidone prescribed as recorded in the CPRD in the UK |
|
|
| Olanzapine | Drug | Olanzapine prescribed as recorded in the CPRD in the UK |
|
|
| Ziprasidone | Drug | Ziprasidone prescribed as recorded in the CPRD in the UK |
|
| Iloperidone | Drug | Iloperidone prescribed as recorded in the CPRD in the UK |
|
| Paliperidone | Drug | Paliperidone prescribed as recorded in the CPRD in the UK |
|
| Lurasidone | Drug | Lurasidone prescribed as recorded in the CPRD in the UK |
|
| Clozapine | Drug | Clozapine prescribed as recorded in the CPRD in the UK |
|
| Amisulpride | Drug | Amisulpride prescribed as recorded in the CPRD in the UK |
|
| Sertindole | Drug | Sertindole prescribed as recorded in the CPRD in the UK |
|
| Zotepine | Drug | Zotepine prescribed as recorded in the CPRD in the UK |
|
| Baseline observation period (minimum of at least 365 days prior to date of prescription) |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D013844 | Thiazoles |
| D054833 | Isoindoles |
| D003984 | Dibenzazepines |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |