Phase 4
N=267
Examining Tolerance to CNS Stimulants in ADHD
Attention-deficit/Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02039908 ↗Enrolled (actual)
267
Serious AEs
0.6%
Results posted
Sep 2019
Primary outcome: Primary: Number of Dose Changes Required Per Protocol — 1.79; 1.61 Number of Increases
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methylphenidate (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Florida International University
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Dose Changes Required Per Protocol |
1.79; 1.61 | — |
| SECONDARY Time to First Dose Increase |
3.8; 4.1 | — |
| SECONDARY Endpoint Medication Dose |
1.30; 1.24 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of attention-deficit/hyperactivity disorder
- Full Scale IQ above 80
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02039908). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.