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NCT02039908 · ClinicalTrials.gov registry record · Phase 4

Examining Tolerance to CNS Stimulants in ADHD

A Phase 4 study, sponsored by Florida International University.

Completed
Registry status
Phase 4
Development phase
267
Enrollment target

NCT02039908 is a Phase 4 study that has completed, run by Florida International University. The registered enrollment target is 267 participants.

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The verdict

NCT02039908, a Phase 4 study, has completed, sponsored by Florida International University.

COMPLETED
Registry status
Phase 4
Development phase
267 participants
Enrollment target

Study Summary

Although stimulant medication is a well-established treatment for ADHD, it is often necessary for doctors to increase the dose over time to maintain the benefits of the medication. While medication can be very effective for improving symptoms of ADHD during the first year of use, it has not been found to significantly improve the long term course of children with ADHD. For example, in large research studies, groups of children who take medication for ten years do not have consistently better academic grades than groups of children who never used medication (individual results will vary from child to child). In order to help children with ADHD achieve the best possible outcomes, it is important for doctors to study why this happens. One possible reason is development of tolerance to the medication. Tolerance means that a drug's effects decrease when it is taken consistently over time, so that an increased dose is needed to continue showing effects. Some doctors believe that children who take stimulant medication for ADHD develop tolerance to it which would explain why benefits may not persist over time, but no research studies have been done to measure whether this occurs. This study aims to see if children show a tolerance effect to stimulant medication and whether that tolerance can be prevented by taking short breaks from the medication called medication holidays.

Interventions

  • DRUG Methylphenidate

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2013-04
Est. Completion 2020-03
Phase Phase 4

Sponsor

Florida International University

89 total trials

What the Registry Record Tells You About NCT02039908

The ClinicalTrials.gov registry entry for NCT02039908 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida International University, which has 89 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Methylphenidate is the first listed.

NCT02039908 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02039908 about?

NCT02039908 is a clinical study titled "Examining Tolerance to CNS Stimulants in ADHD". Although stimulant medication is a well-established treatment for ADHD, it is often necessary for doctors to increase the dose over time to maintain the benefits of the medication. While medication can be very effective for improving symptoms of ADHD during the first year of use, it has not been fou...

What is the current status of trial NCT02039908?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 267 participants. The study started on 2013-04. Estimated completion is 2020-03.

What interventions are being tested in trial NCT02039908?

The interventions under investigation include: Methylphenidate (DRUG).

Who is sponsoring clinical trial NCT02039908?

This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.