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

2019-10-24 12:49:32 | BioPortfolio

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.

Study Design

Conditions

Attention Deficit Disorder With Hyperactivity

Intervention

Methylphenidate, Lisdexamfetamine, Atomoxetine, Amphetamine, Dextroamphetamine

Location

Janssen Investigative Site
Titusville
New Jersey
United States
08560

Status

Recruiting

Source

Janssen Research & Development, LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-24T12:49:32-0400

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Medical and Biotech [MESH] Definitions

A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

A central nervous system stimulant used most commonly in the treatment of attention-deficit disorders in children and for narcolepsy. Its mechanisms appear to be similar to those of DEXTROAMPHETAMINE.

The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.

A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.

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