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Examining Tolerance to CNS Stimulants in ADHD

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ClinicalTrials.gov Identifier: NCT02039908
Recruitment Status : Completed
First Posted : January 20, 2014
Results First Posted : September 17, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Florida International University

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Attention-deficit/Hyperactivity Disorder Drug: Methylphenidate Phase 4

Detailed Description:

This is an innovative evaluation of tolerance using an objective measure in an analog classroom. Each subject will complete the a 10-minute math test twice a day for three weeks on optimal dose or placebo, and then be crossed over to the other condition. Within-subject drug/placebo differences will be compared over the three weeks of exposure to assess tolerance in the analog setting.

When school commences, 50% of the sample will be randomized to 7-day-a-week (continuous) dosing and 50% to 5-day-a- week (weekend holidays) dosing to examine the efficacy of prescribed weekend drug holidays for combatting need for dose escalations (tolerance) during the school year.

Participants will be assessed monthly to detect deteriorating functioning. Using a standardized protocol, study physicians will increase dose for subjects in either arm who meet defined impairment thresholds. The difference between the two dosing conditions will inform regarding how best to deal with tolerance in clinical application.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Examining Tolerance to CNS Stimulants in ADHD
Study Start Date : April 2013
Actual Primary Completion Date : May 2018
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Methylphenidate 7-day dosing
During the school year, children in this arm will receive 7-day dosing of medication.
 Drug: Methylphenidate
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.
Other Name: Concerta
Active Comparator: Methylphenidate 5-day dosing
During the school year phase, these children will receive 5-day dosing with weekend holidays.
 Drug: Methylphenidate
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.
Other Name: Concerta


Outcome Measures
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Primary Outcome Measures :
  1. Number of Dose Changes Required Per Protocol [ Time Frame: 10 months ]
    Monthly evaluations of medication efficacy will be used to determine whether dose adjustments are needed due to anticipated tolerance effects.


Secondary Outcome Measures :
  1. Time to First Dose Increase [ Time Frame: 10 months ]
    The amount of time elapsed before a child requires a dose increase during the school year will be measured in months.

  2. Endpoint Medication Dose [ Time Frame: End of Phase 2 School Year ]
    Dose of medication reported in mg/kg/day


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02039908


Locations
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United States, Florida
Florida International University Center for Children and Families
Miami, Florida, United States, 33199
Sponsors and Collaborators
Florida International University
Investigators
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Principal Investigator: William E Pelham, Ph.D. Florida International University
Principal Investigator: James M Swanson, Ph.D. Florida International University
  Study Documents (Full-Text)

Documents provided by Florida International University:
Study Protocol and Statistical Analysis Plan  [PDF] January 22, 2013

More Information
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Additional Information:

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Responsible Party: Florida International University
ClinicalTrials.gov Identifier: NCT02039908    
Other Study ID Numbers: MH099030
First Posted: January 20, 2014    Key Record Dates
Results First Posted: September 17, 2019
Last Update Posted: June 9, 2020
Last Verified: May 2020
Keywords provided by Florida International University:
Tolerance to stimulant medication
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
 Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents