CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 267 enrolled
Drug / intervention
Methylphenidatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02039908
NCT02039908Phase 4Completed

Examining Tolerance to CNS Stimulants in ADHD

Florida International University·interventional·Posted Jan 20, 2014·Updated Jun 9, 2020

In Brief

A Phase 4 clinical trial evaluating Methylphenidate for Attention-deficit/Hyperactivity Disorder. Completed, enrolled 267 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 20, 2014
Enrollment StartApr 1, 2013
Primary CompletionMay 1, 2018
Study CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 12.5 years ago

Interventions

Methylphenidatedrug

Children will receive a double-blind assessment to determine their optimal starting dose of Concerta. Doses will be adjusted over the course of the school year and inceased if tolerance to the medication is detected.