Status:
COMPLETED
The Effects of ADHD Medication (TEAM) Study
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Seattle Children's Hospital
Conditions:
ADHD
Eligibility:
All Genders
7-11 years
Phase:
PHASE4
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...
Detailed Description
The stimulant methylphenidate (MPH) is the most commonly prescribed psychoactive medication in children. An abundance of studies attest to the efficacy of MPH for attenuating inattentive, hyperactive,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT02293655
Start Date
January 12 2015
End Date
June 30 2021
Last Update
December 21 2023
Active Locations (2)
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1
Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
2
Seattle Children's Hospital
Seattle, Washington, United States, 98105