Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
Condition: ADHD; Growth
Intervention: behavior therapy; Extended release (ER) methylphenidate product; monitoring; drug holiday; caloric supplement
Intervention description: combination of individual and group parent training plus school consultation; medication to be taken daily for duration of study unless assigned to weight promotion arm; monthly weight, height and BMI checks; switch from seven day a week dosing to medication only on school days; continue current ADHD regimen and add one 8oz liquid caloric supplement at night
Intervention MeSH terms: Methylphenidate; Central Nervous System Stimulants
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: initial randomization to behavior or extended release stimulant (ER stimulant) arms.
Participants in either arm meting criteria for a weight recovery intervention (based on change in zBMI) will be adaptively randomized to one of three weight recovery arms (Monitoring, Drug Holiday, Caloric Supplementation)
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD; growth; BMI; stimulant medication

Summary:

      Previous NIH funded Attention Deficit Hyperactivity Disorder (ADHD) trials in children found
      that daily stimulant therapy produced sustained growth deficits. However, no federally funded
      studies have examined the growth suppression associated with modern once a day stimulant
      medications. Therefore, this study will precisely estimate the risks of stimulant induced
      growth suppression (SIGS), examine the underlying mechanisms and develop treatments for it.
      While drug holidays and caloric supplementation are two common treatments for SIGS, there has
      been little systematic investigation of either. It is unknown if they are effective or
      feasible. Therefore, using a randomized adaptive design, we will evaluate the efficacy and
      feasibility of these two practices vs. routine monitoring of growth in 180 prepubertal
      children with ADHD. An additional 50 subjects will be treated solely with behavioral
      therapies to evaluate for growth abnormalities associated with ADHD. The study will assess
      will the risk of SIGS with ER stimulants and the underlying mechanisms while providing
      evidenced-based treatments for its management.
    

Eligibility criteria:

        Inclusion Criteria:

          -  children meeting criteria for any subtype of ADHD between the ages of 5-12 who are
             stimulant naive

        Exclusion Criteria:

          -  Children who meet any of the following criteria will not be eligible to participate in
             this study:

               -  children with a Full Scale Intelligence Quotient (I below 70 as children with IQs
                  less than this would likely not benefit from the behavior therapy intervention

               -  not in full time school or less than 5 or older than 12 years at the time of the
                  screening visit

               -  children who have a history of seizures or other neurological problems and are
                  taking medication to prevent seizures as stimulants could worsen seizures

               -  children with a history of other medical problems for whom psychostimulant
                  treatment may involve considerable risk including cardiac arrhythmias,
                  hypertension, Tourette's Disorder or history of severe tic exacerbations
                  secondary to stimulant exposure

               -  children with a history of other medical problems that could impact appetite or
                  weight such as hypothyroidism, diabetes mellitus, liver or renal disease. Also,
                  children using prescription medication that can significantly impact appetite or
                  weight are excluded

               -  children with a childhood history or diagnosis of any of the following mental
                  health disorders: pervasive developmental disorder, schizophrenia or other
                  psychotic disorders, bipolar disorder, post traumatic stress disorder, major
                  depression with serious suicidal thoughts or an eating disorder as stimulants are
                  not safe and effective treatments for these conditions, and these diseases could
                  affect eating habits

               -  children whose Body Mass Index is very low (too light for safe use of stimulant
                  medication) or is too high (overweight so not suitable for weight promotion
                  treatments)

               -  children allergic to milk proteins as they are in the caloric supplement (lactose
                  intolerance okay)

               -  children previously treated with stimulant medications for more than 30 days as
                  this study is focusing on children who have never used stimulant medication
                  before.