A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group
- Conditions
- Stroke
- Interventions
- Registration Number
- NCT04002700
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1234412
For entry event of an initial drug exposure:
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Comparator Cohort 7 Atypical Antipsychotics Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years without a recent dementia diagnosis. Target Cohort 5 Typical Antipsychotics Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years. Target Cohort 3 Typical Antipsychotics Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged greater than or equal to (\>=) 65 years. Target Cohort 1 Typical Antipsychotics Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years without a recent dementia diagnosis. Comparator Cohort 8 Atypical Antipsychotics Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged \>= 65 years. Comparator Cohort 9 Atypical Antipsychotics Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years. Target Cohort 2 Haloperidol 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 4 Haloperidol Participants will be analyzed for stroke-risk who are new users of haloperidol aged \>= 65 year. Target Cohort 6 Haloperidol Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (1)
Janssen Investigative Site
🇺🇸Titusville, New Jersey, United States