Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| PCSESP001292 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to extend the recent Food and Drug Administration (FDA) Sentinel tabulations regarding stroke risk among new users of typical and atypical antipsychotics to participants who were aged 18-64 years and did not have dementia to participants aged 65 years and older regardless of dementia status.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target Cohort 1 | Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years without a recent dementia diagnosis. |
| |
| Target Cohort 2 | Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years without a recent dementia diagnosis. |
| |
| Target Cohort 3 | Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged greater than or equal to (>=) 65 years. |
| |
| Target Cohort 4 | Participants will be analyzed for stroke-risk who are new users of haloperidol aged >= 65 year. |
| |
| Target Cohort 5 | Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years. |
| |
| Target Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haloperidol | Drug | Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of haloperidol. No drug will be administered as part of this study. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Stroke as a Principal Inpatient Diagnosis | Number of participants with stroke in each target cohort versus comparator cohort (aged 65 years and older) per person years at risk will be reported. It is defined defined by the presence of the relevant ICD codes (ICD-9 or ICD-10 according to date) in the inpatient setting as the primary diagnoses. | Up to 16 years (from 01-January-2002 through 31-December-2017) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants at Stroke Risk when Compared Among New Users of Typical Antipsychotics/Haloperidol versus Atypical Antipsychotics | The number of participants with the risk of stroke among participants exposed to typical antipsychotics versus atypical antipsychotics will be reported. | Up to 16 years (from 01-January-2002 through 31-December-2017) |
Not provided
Inclusion Criteria:
For entry event of an initial drug exposure:
Not provided
Not provided
Not provided
The study population is the participants in (any of) the target or comparator cohorts. Each target and comparator cohort will be drawn from the appropriate database: IBM MarketScan Commercial Database (CCAE) if the participants are aged 18-64 years and IBM MarketScan Medicare Supplemental Database (MDCR) if participants are aged greater than or equal to (>=) 65 years.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Janssen Investigative Site | Titusville | New Jersey | 08560 | United States |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years.
|
| Comparator Cohort 7 | Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years without a recent dementia diagnosis. |
|
| Comparator Cohort 8 | Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged >= 65 years. |
|
| Comparator Cohort 9 | Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years. |
|
| Typical Antipsychotics | Drug | Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of typical antipsychotics which includes Haloperidol, Loxapine, Thioridazine, Molindone, Thiothixene, Fluphenazine, Trifluoperazine, Perphenazine, Chlorpromazine. No drug will be administered as part of this study. |
|
| Atypical Antipsychotics | Drug | Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of atypical antipsychotics which includes Aripriprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Paliperidone, Ziprasidone, Risperidone, Quetiapine, Olanzapine. No drug will be administered as part of this study. |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |