Examining Tolerance to CNS Stimulants in ADHD

Completed · Phase 4

Conditions studied: Attention-deficit/Hyperactivity Disorder

In brief

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.

Key facts

Study ID

NCT02039908

Run by

Florida International University

People needed

267

Starts

2013-04-01

Expected to finish

2020-03-01

Last updated by the study team

2020-06-09

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of attention-deficit/hyperactivity disorder
• Full Scale IQ above 80

You may not qualify if…

• Psychotropic medications for conditions other than ADHD
• Active medical or psychiatric conditions that could be worsened by stimulants
• Diagnosis of Autism or Asperger's Disorder
• Documented intolerance fo methylphenidate or failed trial of OROS MPH

Where it is running

• Florida International University Center for Children and Families — Miami, Florida, United States

Full record on ClinicalTrials.gov

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