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Phase 4 N=267 Randomized Quadruple-blind Treatment

Examining Tolerance to CNS Stimulants in ADHD

Attention-deficit/Hyperactivity Disorder

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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