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

NCT04132557 | Completed FDA Drug

• 2 other identifiers: CR108701PCSESP002036
• Study Type: observational
• Target: 430,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (5)

• Number of Incidence of Suicide Attempt or Ideation

  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

  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

  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

  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

  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

Study Arms (4)

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

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

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

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; Drug: Dextroamphetamine

Interventions

Methylphenidate DRUG

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 1 (Target): Methylphenidate Monotherapy

Lisdexamfetamine DRUG

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 2 (Comparator [C]): Lisdexamfetamine Monotherapy

Atomoxetine DRUG

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 3 (C): Atomoxetine Monotherapy

Amphetamine DRUG

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.

Cohort 4 (C):Amphetamine/Dextroamphetamine Combo Therapy

Dextroamphetamine DRUG

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.

Cohort 4 (C):Amphetamine/Dextroamphetamine Combo Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Janssen Investigative Site

Titusville, New Jersey, 08560, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Lisdexamfetamine Dimesylate; Atomoxetine Hydrochloride; Amphetamine; Dextroamphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amphetamines; Phenethylamines; Ethylamines; Amines; Propylamines

Study Officials

• Janssen Research and Development, LLC Clinical Trial

  Janssen Research and 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: October 17, 2019
• First Posted: October 21, 2019
• Study Start: October 9, 2019
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

US (1)