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

NCT04002700 | Completed FDA Drug

• 2 other identifiers: CR108624PCSESP001292
• Study Type: observational
• Target: 1,234,412
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (9)

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

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

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

Target Cohort 4

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

Drug: Haloperidol

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

Target Cohort 6

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

Drug: Haloperidol

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

Comparator Cohort 8

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

Drug: Atypical Antipsychotics

Comparator Cohort 9

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

Drug: Atypical Antipsychotics

Interventions

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.

Target Cohort 2; Target Cohort 4; Target Cohort 6

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.

Target Cohort 1; Target Cohort 3; Target Cohort 5

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.

Comparator Cohort 7; Comparator Cohort 8; Comparator Cohort 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Janssen Investigative Site

Titusville, New Jersey, 08560, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 1, 2019
• Study Start: May 6, 2019
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

US (1)