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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Attention Deficit Disorder With Hyperactivity

Treatments: Drug: Atomoxetine; Drug: Dextroamphetamine; Drug: Amphetamine; Drug: Lisdexamfetamine; Drug: Methylphenidate

Study type: Observational

Funder types: Industry

Identifiers

NCT04132557

CR108701

PCSESP002036 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 430,000 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

430,000 participants in 4 patient groups

Cohort 1 (Target): Methylphenidate Monotherapy

Description:

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.

Treatment:

Drug: Methylphenidate

Cohort 2 (Comparator [C]): Lisdexamfetamine Monotherapy

Description:

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.

Treatment:

Drug: Lisdexamfetamine

Cohort 3 (C): Atomoxetine Monotherapy

Description:

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.

Treatment:

Drug: Atomoxetine

Cohort 4 (C):Amphetamine/Dextroamphetamine Combo Therapy

Description:

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.

Treatment:

Drug: Dextroamphetamine

Drug: Amphetamine