Phase 4
Completed N=109
The Effects of ADHD Medication (TEAM) Study
Source: ClinicalTrials.gov NCT02293655 ↗Enrolled (actual)
109
Serious AEs
0.9%
Results posted
Feb 2022
Primary outcomePrimary: Parent ADHD Total Symptom Scores — 36.2; 34.6; 17.6; 15.3 score on a scale — p=0.55
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parent ADHD Total Symptom Scores |
36.2; 34.6; 17.6; 15.3; 16.5; 12.3 | 0.55 |
| PRIMARY Inhibitory Control Reaction Time Variability (SD of the Reaction Time) |
219.6; 196.0; 195.9; 199.6; 250.8; 183.8 | .32 |
| PRIMARY Math Computation - Number of Problems Completed Correctly |
200.84; 230.93; 264.71; 320.12; 221.19; 333.50 | .33 |
| PRIMARY % Time on Task |
74.4; 85.2; 83.9; 92.7; 73.1; 91.5 | — |
| SECONDARY Barkley Sluggish Cognitive Tempo (SCT) Ratings |
24.41; 24.19; 18.5; 18.2; 18.4; 17.5 | — |
| SECONDARY Parent Ratings of Emotional Regulation |
2.1; 2.1; 1.8; 1.8; 1.8; 1.7 | — |
| SECONDARY Spatial Working Memory |
6.43; 6.83; 6.46; 6.63; 6.67; 7.42 | — |
| SECONDARY Math Reasoning |
1.0; 1.0; 1.09; 1.27; 1.11; 1.50 | — |
| SECONDARY Reading Comprehension |
1.00; 1.00; 1.00; 0.99; 1.02; 1.25 | — |
| SECONDARY Written Expression |
1.00; 1.00; 1.16; 0.94; 1.02; 1.06 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02293655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.