Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
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.
The study will consist of 4 parts:

 1. Screening assessment to determine if a child has ADHD and would be a good candidate to
 have their ADHD treated with an extended release (ER) stimulant medication. If the
 answer to step one is yes, then the child will be randomly assigned to receive either
 medication treatment with an extended release MPH product (OROS MPH). 78% of children
 with start with this option with 22% assigned to behavioral therapy/counseling
 treatments for ADHD. There will be no placebo treatments used in this study. All
 children must be between the ages of 5 and 12 and never have taken stimulant medications
 for ADHD for more than one week to be eligible for the study.

 2. Initial Treatment Phase: The dose of the assigned treatment option will be gradually
 adjusted over the course of the first 3 months until the child's ADHD is well
 controlled. If the child is assigned to medication, he/she will start with a low dose of
 the ER MPH product, and it will be gradually increased until his/her ADHD is in good
 control. Children assigned to medication will be asked to take it every day of the week
 for at least the first 6 months. Children assigned to behavior therapy will be asked to
 avoid using medication for the first 6 months of the study. After month 6 if the first
 treatment is not effective, the child will be given the chance to try the other option.
 If any treatment is causing a concerning side effect, he/she can stop taking it at any
 time and we will provide him/her with other treatment options as part of the study.

 3. Ongoing Treatment Phase: We will continue to provide these ADHD treatments for a total
 of 30 months (2 1/2 years). The dose or type of therapy may be adjusted if needed. The
 child will be monitored every 1-3 months over this time span. Monitoring includes doctor
 visits to assess growth and side effects of medication, regular contact with his/her
 teacher to assess function at school and with you to assess function at home. In total,
 the child will receive study treatments for approximately 30 months and will be required
 to come to our center for a minimum of 18 follow up visits over this time. The average
 visit should take 30 minutes or less.

 4. Weight Recovery Phase: Any child whose body mass index or BMI declines by a concerning
 amount will be randomly assigned to receive 1 of 3 weight promotion treatments to
 stabilize his/her BMI in order to see if this prevents suppression of height (keeps them
 growing to be as tall as they should be). We do not expect children assigned to the
 behavior therapy arm to need these treatments, but the identical weight promotion
 treatments will be available for children in this group if the need arises.

 A) Extra monitoring: A doctor will check the child's growth every month (instead of every 3
 months) until his/her BMI has returned to normal.The child will stay on the current daily
 dose of medication or behavior therapy.

 B) Caloric supplementation: Parents will be provided with a flavored calorie drink to give to
 your child every night and continue on the same daily dose and frequency of medication or
 behavior therapy. The child will have their growth monitored monthly by a study doctor.

 C) Drug Holiday: Participants will now only take medication on school days. Children assigned
 to behavior therapy will not participate in this treatment as they are not taking any study
 medication. The child will have their growth monitored monthly by a study doctor.

 Once the child's weight recovers, these extra treatments will end and he/she will return to
 the prior medication treatment (medication7 days a week or behavior therapy) in step 3 and to
 every 3 month growth assessments. Any time the child's BMI declines again, the extra
 treatments will restart again.
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.