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Examining Tolerance to CNS Stimulants in ADHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
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
 (submitted: January 16, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
  • 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.
  • Endpoint Medication Dose [ Time Frame: End of Phase 2 School Year ]
    Dose of medication reported in mg/kg/day
Original Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2014)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: January 16, 2014)
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.
 
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.

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 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
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
Study Arms  ICMJE
  • Active Comparator: Methylphenidate 7-day dosing
    During the school year, children in this arm will receive 7-day dosing of medication.
    Intervention: Drug: Methylphenidate
  • Active Comparator: Methylphenidate 5-day dosing
    During the school year phase, these children will receive 5-day dosing with weekend holidays.
    Intervention: Drug: Methylphenidate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2019)
267
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2014)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Responsible Party Florida International University
Study Sponsor  ICMJE Florida International University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William E Pelham, Ph.D. Florida International University
Principal Investigator: James M Swanson, Ph.D. Florida International University
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