Examining Tolerance to CNS Stimulants in ADHD

NCT02039908 | Completed Phase 4 Results DMC

• 1 other identifier: MH099030
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-deficit/Hyperactivity Disorder

Keywords

Tolerance to stimulant medication

Outcome Measures

Primary Outcomes (1)

• Number of Dose Changes Required Per Protocol

  Monthly evaluations of medication efficacy will be used to determine whether dose adjustments are needed due to anticipated tolerance effects.

  10 months

Secondary Outcomes (2)

• Time to First Dose Increase

  10 months

• Endpoint Medication Dose

  End of Phase 2 School Year

Study Arms (2)

Methylphenidate 7-day dosing

ACTIVE COMPARATOR

During the school year, children in this arm will receive 7-day dosing of medication.

Drug: Methylphenidate

Methylphenidate 5-day dosing

ACTIVE COMPARATOR

During the school year phase, these children will receive 5-day dosing with weekend holidays.

Drug: Methylphenidate

Interventions

Methylphenidate DRUG

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.

Also known as: Concerta

Methylphenidate 5-day dosing; Methylphenidate 7-day dosing

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of attention-deficit/hyperactivity disorder
• Full Scale IQ above 80

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University Center for Children and Families

Miami, Florida, 33199, United States

Location

Related Publications (1)

• 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.

  PMID: 35604744 DERIVED

Related Links

• Center for Children and Families General Information

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: William E. Pelham, Jr., Ph.D.
• Organization: Florida International University

wpelham@fiu.edu

305-348-0477

Study Officials

• William E Pelham, Ph.D.

  Florida International University

  PRINCIPAL INVESTIGATOR

• James M Swanson, Ph.D.

  Florida International University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2013
• First Posted: January 20, 2014
• Study Start: April 1, 2013
• Primary Completion: May 1, 2018
• Study Completion: March 1, 2020
• Last Updated: June 9, 2020
• Results First Posted: September 17, 2019

Record last verified: 2020-05

Locations

US (1)