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NCT04132557 · ClinicalTrials.gov registry record
A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine
A clinical trial, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 430,000
- Enrollment target
NCT04132557: Completed study, sponsored by Janssen Research & Development.
NCT04132557 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 430,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04132557 has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 430,000 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Methylphenidate
- DRUG Atomoxetine
- DRUG Lisdexamfetamine
- DRUG Amphetamine
- DRUG Dextroamphetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 430,000 participants |
| Start Date | 2019-10-09 |
| Est. Completion | 2019-10-25 |
What the finished NCT04132557 record still lists
NCT04132557 is an observational study that tracks outcomes without assigning an intervention. Its 430,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 5 interventions - of which Methylphenidate is the first listed.
NCT04132557 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04132557 about?
NCT04132557 is a clinical study titled "A Study on Suicidality, Psychosis or Substance Abuse With Methylphenidate, Atomoxetine, Amphetamine/Dextroamphetamine or Lisdexamfetamine". 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 th...
What is the current status of trial NCT04132557?
This trial is currently completed. The enrollment target is 430,000 participants. The study started on 2019-10-09. Estimated completion is 2019-10-25.
What interventions are being tested in trial NCT04132557?
The interventions under investigation include: Methylphenidate (DRUG), Atomoxetine (DRUG), Lisdexamfetamine (DRUG), Amphetamine (DRUG), Dextroamphetamine (DRUG).
Who is sponsoring clinical trial NCT04132557?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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