Phase 3
N=230
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
ADHD · Growth
Bottom Line
View on ClinicalTrials.gov: NCT01109849 ↗Enrolled (actual)
230
Serious AEs
2.6%
Results posted
Jul 2017
Primary outcome: Primary: Change Score for Z-height Baseline to Endpoint — -.04; -.11 Z score
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- behavior therapy (Behavioral); Extended release (ER) methylphenidate product (Drug); monitoring (Other); drug holiday (Other); caloric supplement (Dietary_supplement)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Florida International University
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change Score for Z-height Baseline to Endpoint |
-.04; -.11 | — |
| SECONDARY Change Score for z Weight |
-.01; -.19 | — |
| SECONDARY Change in zBody Mass Index (BMI) |
-.06; -.21 | — |
| SECONDARY Treatment Adherence for Caloric Supplement |
70 | — |
| SECONDARY ADHD Symptoms- Parent Rated |
15.6; 15.2 | — |
| SECONDARY Change Score for Zheight Months 0 to 6 |
0.00; -0.035 | — |
| SECONDARY ADHD Symptoms- Teacher Rated |
14.5; 13.8 | — |
| SECONDARY Medication Adherence |
68.1; 71.1 | — |
| SECONDARY Number of Behavior Therapy Sessions |
8.1; 8.1 | — |
| SECONDARY Change in Height z Score During Weight Recovery Phase (Second Randomization) |
-0.185; -0.030; -0.168 | — |
| SECONDARY Change in Weight z Score During Weight Recovery Phase (Second Randomization) |
0.050; 0.262; 0.062 | — |
| SECONDARY Change in Zscore for BMI During Weight Recovery Phase (Second Randomization) |
0.243; 0.443; 0.247 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01109849). 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.