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
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Tracking Information | |||||||
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First Submitted Date ICMJE | March 7, 2013 | ||||||
First Posted Date ICMJE | January 20, 2014 | ||||||
Results First Submitted Date ICMJE | July 29, 2019 | ||||||
Results First Posted Date ICMJE | September 17, 2019 | ||||||
Last Update Posted Date | June 9, 2020 | ||||||
Study Start Date ICMJE | April 2013 | ||||||
Actual Primary Completion Date | May 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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 weeks.
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures |
Symptom ratings [ Time Frame: 12 months ] ADHD symptoms will be measured at the end of the school year along with associated measures of social skills and academic performance.
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Descriptive Information | |||||||
Brief Title ICMJE | Examining Tolerance to CNS Stimulants in ADHD | ||||||
Official Title ICMJE | Examining Tolerance to CNS Stimulants in ADHD | ||||||
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. |
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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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Attention-deficit/Hyperactivity Disorder | ||||||
Intervention ICMJE | 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
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Study Arms ICMJE |
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Publications * | Pelham WE, Altszuler AR, Merrill BM, Raiker JS, Macphee FL, Ramos M, Gnagy EM, Greiner AR, Coles EK, Connor CM, Lonigan CJ, Burger L, Morrow AS, Zhao X, Swanson JM, Waxmonsky JG, Pelham WE. The effect of stimulant medication on the learning of academic curricula in children with ADHD: A randomized crossover study. J Consult Clin Psychol. 2022 May;90(5):367-380. doi: 10.1037/ccp0000725. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
267 | ||||||
Original Estimated Enrollment ICMJE |
250 | ||||||
Actual Study Completion Date ICMJE | March 2020 | ||||||
Actual Primary Completion Date | May 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Years to 12 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02039908 | ||||||
Other Study ID Numbers ICMJE | MH099030 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Florida International University | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Florida International University | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Florida International University | ||||||
Verification Date | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |