The Effects of ADHD Medication (TEAM) Study

NCT02293655 | Completed Phase 4 Results DMC

• 1 other identifier: ADHDMedTEAMStudy
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the effects of receiving and then discontinuing methylphenidate (MPH) in children with ADHD. After receiving MPH for 8 weeks, participants will be randomized to either discontinue MPH (and receive placebo) OR remain on MPH for 4 weeks.

Conditions

ADHD

Keywords

ADHD; inattention; hyperactivity; methylphenidate

Outcome Measures

Primary Outcomes (4)

• Parent ADHD Total Symptom Scores

  Parent Vanderbilt ADHD Rating Scale Total Symptom Score, minimum=0, maximum=54, higher scores indicate more/worse ADHD symptoms

  baseline, study weeks 8, 9, 10, 12

• Inhibitory Control Reaction Time Variability (SD of the Reaction Time)

  Assessed via the Go/No-Go computerized measure of inhibitory control reaction time variability (with standard deviation of the reaction time being the indicator variability variability). Unit of measure is msec. Minimum is 0, Maximum is 500. Higher scores indicate more variability (higher standard deviation) in reaction time, indicating worse outcome (more characteristic of individuals with ADHD and less characteristic of typically developing individuals).

  baseline, study weeks 8, 9, 10 & 12

• Math Computation - Number of Problems Completed Correctly

  Math Computation Curriculum-Based Measure - Number of Problems Completed Correctly. Minimum=0, Maximum=600. Higher scores indicate improved/better performance

  baseline, study weeks 8, 9, 10 & 12

• % Time on Task

  Participants were videotaped while completing the 20-minute Analogue Math task. Their behavior was coded in 20-second intervals by trained coders who determined if the children were on-task or off-task during each interval. The amount of time coded as on-task was divided by the total amount of time and then multiplied by 100 to generate the % of time on task variable.

  baseline, study weeks 8, 9, 10, 12

Secondary Outcomes (6)

• Barkley Sluggish Cognitive Tempo (SCT) Ratings

  baseline, study weeks 8, 9, 10 &12

• Parent Ratings of Emotional Regulation

  baseline, study weeks 8, 9, 10 &12

• Spatial Working Memory

  baseline, study weeks 8, 9, 10 &12

• Math Reasoning

  baseline, study weeks 1, 8, 9, 10 &12

• Reading Comprehension

  baseline, study weeks 8, 9, 10 &12

Study Arms (2)

MPH Discontinuation

PLACEBO COMPARATOR

1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion. 2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks. 3. DB 4-week MPH Discontinuation Phase. Pts in this arm will receive placebo (qAM).

Drug: OROS-Methylphenidate (MPH)

Sustained MPH

ACTIVE COMPARATOR

1. Double-blind (DB) placebo-controlled 4-week methylphenidate (MPH) titration trial. Pts will receive 3 active dosages of MPH (children \<25kg: 18mg, 27mg, 36mg; children \>25kg: 18mg, 36mg, 54mg for) as well as 1 random week of placebo, given qAM. Pts will begin on the lowest dose (or a randomized placebo week) and proceed through all dose conditions in an incremental fashion. 2. DB 4-week MPH maintenance phase. The clinician, parent, and teacher ratings of behavior and side effects from the titration trial weeks will be graphed. Two doctors will blindly review the graphs and judge which week was the optimal dose week. Pts will then receive their optimal dose of MPH (qAM) for 4 weeks. 3. DB 4-week MPH Discontinuation Phase. Pts in this arm will continue their optimal MPH dose (qAM).

Drug: OROS-Methylphenidate (MPH)

Interventions

OROS-Methylphenidate (MPH) DRUG

OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.

Also known as: Concerta

MPH Discontinuation; Sustained MPH

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ADHD Diagnostic Status: Meets DSM-V criteria for ADHD, with Clinical Global Impression (CGI) rating corresponding to at least "moderately ill."
• Cognitive and Academic Functioning: Intelligence Quotient (IQ) of \>80 as estimated by Vocabulary and Block Design subtests of the Wechsler Intelligence Scale for Children-4th Edition and scaled scores \>80 on the Wechsler Individual Achievement Test-2nd edition Reading and Math subtests
• Physical Health: Physical exam and ECG findings are judged to be normal for age and sex by study physician and/or medical consultant, and there is no co-existing condition for which MPH is contraindicated 4. School: Enrolled in a school setting rather than a home-school program. This ensures that we can obtain parent and teacher ratings from separate individuals for diagnosis and outcome assessment

You may not qualify if:

• Psychiatric Medications: Current or prior use of any medication for psychological/psychiatric problems
• Behavioral Interventions: Current active participation in ADHD-related behavioral interventions, given that improvements due to these interventions may confound our group comparisons
• Psychiatric or Neurobehavioral Conditions: Children with mania/hypomania, schizophrenia, or severe depressive disorder, as determined by the K-SADS, will be excluded since ADHD medications may not be an appropriate first line of treatment for children with these comorbid disorders
• Organic Brain Injury: History of head trauma, neurological disorder (including epilepsy), or other disorder affecting brain function due to potential differences in neurophysiology of ADHD phenotype
• Cardiovascular Risk Factors: Children with a personal history or family history of cardiovascular risk factors will be excluded, or given the option of participating in the study after obtaining an EKG and verification from a pediatric cardiologist regarding the safety of their participation in a trial of methylphenidate. In this case, families will be responsible for the costs of EKG and any necessary cardiologist evaluation
• Pregnancy: The safety of MPH use during pregnancy has not been established

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Seattle Children's Hospital: collaborator

Study Sites (2)

Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Spasm

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Note that the school direct observations outcome was not collected due to data collection not being feasible due to schools' privacy concerns about other students in the classroom. All other outcome measures that were pre-specified Primary or Secondary Outcome Measures have been reported in this ClinicalTrials.gov entry.

Results Point of Contact

• Title: Tanya Froehlich, MD
• Organization: Cincinnati Children's Hospital Medical Center

tanya.froehlich@cchmc.org

5136361154

Study Officials

• Tanya E. Froehlich, MD

  Children's Hospital Medical Center, Cincinnati

  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: October 29, 2014
• First Posted: November 18, 2014
• Study Start: January 12, 2015
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: December 21, 2023
• Results First Posted: February 4, 2022

Record last verified: 2023-11

Locations

US (2)