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

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ClinicalTrials.gov Identifier: NCT04132557
Recruitment Status : Completed
First Posted : October 21, 2019
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Attention Deficit Disorder With Hyperactivity Drug: Methylphenidate Drug: Lisdexamfetamine Drug: Atomoxetine Drug: Amphetamine Drug: Dextroamphetamine

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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 : October 9, 2019
Actual Primary Completion Date : October 25, 2019
Actual Study Completion Date : October 25, 2019


Group/Cohort 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.




Primary Outcome Measures :
  1. Number of Incidence of Suicide Attempt or Ideation [ Time Frame: 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.

  2. Number of Incidence of Suicide Attempt [ Time Frame: 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.

  3. Number of Incidence of Suicide Ideation [ Time Frame: 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.

  4. Number of Incidence of Psychosis diagnosis Followed by Anti-psychotic Drug Within 60 days [ Time Frame: 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.

  5. Number of Incidence of Substance Abuse [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04132557


Locations
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United States, New Jersey
Janssen Investigative Site
Titusville, New Jersey, United States, 08560
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research and Development, LLC Clinical Trial Janssen Research and Development LLC

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT04132557     History of Changes
Other Study ID Numbers: CR108701
PCSESP002036 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Substance-Related Disorders
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Chemically-Induced Disorders
Methylphenidate
Amphetamine
Lisdexamfetamine Dimesylate
Dextroamphetamine
Adderall
Atomoxetine Hydrochloride
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents