A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine

June 20, 2025 updated by: Janssen Research & Development, LLC

Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine, a Post-authorization Safety Study

The purpose of this study is to estimate the observed incidence of the health outcomes (suicide attempt or ideation, suicide ideation, suicide attempt, psychosis, and substance abuse) in a cohort of participants diagnosed with attention deficit hyperactivity disorder (ADHD) who are first-line new therapy with methylphenidate monotherapy, lisdexamfetamine monotherapy, atomoxetine monotherapy, amphetamine/dextroamphetamine combo therapy, and either methylphenidate/lisdexamfetamine/atomoxetine monotherapy or amphetamine/dextroamphetamine combo therapy during the 'on treatment' period from 7 days after the start of exposure through the end of exposure (treatment discontinuation for at least 60 days) and the 'intent to treat' period from 7 days after start of treatment to end of continuous observation; and to compare the hazards of outcomes (suicide attempt or ideation, suicide ideation, suicide attempt, psychosis, and substance abuse) in the target cohort (participants diagnosed with ADHD who are first-line monotherapy new users of methylphenidate) versus each comparator cohort (patients diagnosed with ADHD who are first-line newly exposed to lisdexamfetamine monotherapy, atomoxetine monotherapy, amphetamine/dextroamphetamine combo therapy) during the 'on treatment' period from 7 days after the start of exposure through the end of exposure (treatment discontinuation for at least 60 days) and the 'intent to treat' period from 7 days after start of treatment to end of continuous observation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
430000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Titusville, New Jersey, United States, 08560
        • Janssen Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will comprise of participants with attention deficit/hyperactivity disorder (ADHD) described in on three US health care databases and one US electronic health record which has data available through 1 January 2001 to 30 September 2018.

Description

Inclusion Criteria:

  • New users of methylphenidate monotherapy or lisdexamfetamine monotherapy or atomoxetine monotherapy or amphetamine/dextroamphetamine combo therapy
  • Prior diagnosis of ADHD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort 1 (Target): Methylphenidate Monotherapy
Participants will be analyzed for Attention Deficit Hyperactive Disorder (ADHD) who are new users of methylphenidate monotherapy. Analysis of data will be performed between 1 January 2001 to 30 September 2018.
Drug: Methylphenidate
Methylphenidate is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from three United States (US) health care databases and one US electronic health record database.
Cohort 2 (Comparator [C]): Lisdexamfetamine Monotherapy
Participants will be analyzed for ADHD who are new users of lisdexamfetamine monotherapy. Analysis of data will be performed between 1 January 2001 to 30 September 2018.
Drug: Lisdexamfetamine
Lisdexamfetamine is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from three US health care databases and one US electronic health record database.
Cohort 3 (C): Atomoxetine Monotherapy
Participants will be analyzed for ADHD who are new users of atomoxetine monotherapy. Analysis of data will be performed between 1 January 2001 to 30 September 2018.
Drug: Atomoxetine
Atomoxetine is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from on three US health care databases and one US electronic health record database.
Cohort 4 (C):Amphetamine/Dextroamphetamine Combo Therapy
Participants will be analyzed for ADHD who are new users of amphetamine/dextroamphetamine combo therapy. Analysis of data will be performed between 1 January 2001 to 30 September 2018.
Drug: Amphetamine
Amphetamine is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from on three US health care databases and one US electronic health record database.
Drug: Dextroamphetamine
Dextroamphetamine is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from on three US health care databases and one US electronic health record database.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Incidence of Suicide Attempt or Ideation
Time Frame: Up to 17.8 years
Number of incidence of suicide attempt or ideation will be reported. Analysis will be performed from data taken from three United States (US) health care databases and one US electronic health record database.
Up to 17.8 years
Number of Incidence of Suicide Attempt
Time Frame: Up to 17.8 years
Number of incidence of suicide attempt will be reported. Analysis will be performed from data taken from three US health care databases and one US electronic health record database.
Up to 17.8 years
Number of Incidence of Suicide Ideation
Time Frame: Up to 17.8 years
Number of incidence of suicide ideation will be reported. Analysis will be performed from data taken from three US health care databases and one US electronic health record database.
Up to 17.8 years
Number of Incidence of Psychosis diagnosis Followed by Anti-psychotic Drug Within 60 days
Time Frame: Up to 17.8 years
Number of incidence of psychosis diagnosis followed by anti-psychotic drug within 60 days will be reported. Analysis will be performed from data taken from three US health care databases and one US electronic health record database.
Up to 17.8 years
Number of Incidence of Substance Abuse
Time Frame: Up to 17.8 years
Number of incidence of substance abuse (excluding alcohol and nicotine) will be reported. Analysis will be performed from data taken from three US health care databases and one US electronic health record database.
Up to 17.8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research and Development, LLC Clinical Trial, Janssen Research and Development LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108701
  • PCSESP002036 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings