drugset / Trial / NCT02039908

Examining Tolerance to CNS Stimulants in ADHD

NCT02039908

Phase 4 Completed 267 enrolled Florida International University
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-04
Primary completion
2018-05
Completion
2020-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylphenidate Small molecule Oral