A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
NCT ID: NCT04002700
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1234412 participants
OBSERVATIONAL
2019-05-06
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* First exposure to the particular drug(s) in the past 183 days (index date)
* Had at least 183 days of continuous observation time prior to index
* Exactly 0 condition occurrences of 'Cancer' any time in the 183 days before or on the index date
* Exactly 0 condition occurrences of 'Stroke' any time in the 183 days before or on the index date
* Exactly 0 exposures to any other typical or atypical antipsychotics any time in the 183 days before or on the index date
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Janssen Investigative Site
Titusville, New Jersey, United States
Countries
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Other Identifiers
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PCSESP001292
Identifier Type: OTHER
Identifier Source: secondary_id
CR108624
Identifier Type: -
Identifier Source: org_study_id
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