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

Completed

• Conditions: Attention Deficit Disorder With Hyperactivity
• Interventions: Drug: Amphetamine; Drug: Methylphenidate; Drug: Atomoxetine; Drug: Lisdexamfetamine; Drug: Dextroamphetamine

• Registration Number: NCT04132557
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-09
• Study First Submitted: 2019-10-17
• Study First Submitted QC: 2019-10-17
• Study First Posted: 2019-10-21
• Primary Completion: 2019-10-25
• Study Completion: 2019-10-25
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 430000

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 4 (C):Amphetamine/Dextroamphetamine Combo Therapy	Amphetamine	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.
Cohort 1 (Target): Methylphenidate Monotherapy	Methylphenidate	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.
Cohort 3 (C): Atomoxetine Monotherapy	Atomoxetine	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.
Cohort 2 (Comparator [C]): Lisdexamfetamine Monotherapy	Lisdexamfetamine	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.
Cohort 4 (C):Amphetamine/Dextroamphetamine Combo Therapy	Dextroamphetamine	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.

Primary Outcome Measures

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

Janssen Investigative Site; 🇺🇸 Titusville, New Jersey, United States