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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT04132557

Collaborator

(none)

430,000

Enrollment

Location

Actual Duration (Days)

818007.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity	Drug: Methylphenidate Drug: Lisdexamfetamine Drug: Atomoxetine Drug: Amphetamine Drug: Dextroamphetamine

Study Design

Study Type:

Observational

Actual Enrollment :

430000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 9, 2019

Actual Primary Completion Date :

Oct 25, 2019

Actual Study Completion Date :

Oct 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Number of Incidence of Suicide Attempt or Ideation [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.
Number of Incidence of Suicide Attempt [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.
Number of Incidence of Suicide Ideation [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.
Number of Incidence of Psychosis diagnosis Followed by Anti-psychotic Drug Within 60 days [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.
Number of Incidence of Substance Abuse [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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