A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Typical Antipsychotics
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.
|
| 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. |
Drug: Haloperidol
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.
|
| 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. |
Drug: Typical Antipsychotics
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.
|
| Target Cohort 4 Participants will be analyzed for stroke-risk who are new users of haloperidol aged >= 65 year. |
Drug: Haloperidol
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.
|
| Target Cohort 5 Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years. |
Drug: Typical Antipsychotics
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.
|
| Target Cohort 6 Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years. |
Drug: Haloperidol
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.
|
| 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. |
Drug: Atypical Antipsychotics
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.
|
| Comparator Cohort 8 Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged >= 65 years. |
Drug: Atypical Antipsychotics
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.
|
| Comparator Cohort 9 Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years. |
Drug: Atypical Antipsychotics
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.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Stroke as a Principal Inpatient Diagnosis [Up to 16 years (from 01-January-2002 through 31-December-2017)]
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.
Secondary Outcome Measures
- Number of Participants at Stroke Risk when Compared Among New Users of Typical Antipsychotics/Haloperidol versus Atypical Antipsychotics [Up to 16 years (from 01-January-2002 through 31-December-2017)]
The number of participants with the risk of stroke among participants exposed to typical antipsychotics versus atypical antipsychotics will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
For entry event of an initial drug exposure:
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First exposure to the particular drug(s) in the past 183 days (index date)
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Had at least 183 days of continuous observation time prior to index
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Exactly 0 condition occurrences of 'Cancer' any time in the 183 days before or on the index date
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Exactly 0 condition occurrences of 'Stroke' any time in the 183 days before or on the index date
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Exactly 0 exposures to any other typical or atypical antipsychotics any time in the 183 days before or on the index date
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Janssen Investigative Site | Titusville | New Jersey | United States | 08560 |
Sponsors and Collaborators
- Janssen Research & Development, LLC
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR108624
- PCSESP001292