A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Stroke

Treatments: Drug: Haloperidol; Drug: Atypical Antipsychotics; Drug: Typical Antipsychotics

Study type: Observational

Funder types: Industry

Identifiers

NCT04002700

PCSESP001292 (Other Identifier)

CR108624

Details and patient eligibility

About

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.

Enrollment: 1,234,412 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

1,234,412 participants in 9 patient groups

Target Cohort 1

Description:

Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years without a recent dementia diagnosis.

Treatment:

Drug: Typical Antipsychotics

Target Cohort 2

Description:

Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years without a recent dementia diagnosis.

Treatment:

Drug: Haloperidol

Target Cohort 3

Description:

Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged greater than or equal to (\>=) 65 years.

Treatment:

Drug: Typical Antipsychotics

Target Cohort 4

Description:

Participants will be analyzed for stroke-risk who are new users of haloperidol aged \>= 65 year.

Treatment:

Drug: Haloperidol

Target Cohort 5

Description:

Participants will be analyzed for stroke-risk who are new users of typical antipsychotics aged 18 to 64 years.

Treatment:

Drug: Typical Antipsychotics

Target Cohort 6

Description:

Participants will be analyzed for stroke-risk who are new users of haloperidol aged 18 to 64 years.

Treatment:

Drug: Haloperidol

Comparator Cohort 7

Description:

Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years without a recent dementia diagnosis.

Treatment:

Drug: Atypical Antipsychotics

Comparator Cohort 8

Description:

Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged \>= 65 years.

Treatment:

Drug: Atypical Antipsychotics

Comparator Cohort 9

Description:

Participants will be analyzed for stroke-risk who are new users of atypical antipsychotics aged 18-64 years.

Treatment:

Drug: Atypical Antipsychotics