A Randomized Controlled Trial of Interventions for Growth Suppression in Children With Attention-Deficit/Hyperactivity Disorder Treated With Central Nervous System Stimulants - 25/11/20
, William E. Pelham, MA b, Adriana Campa, PhD c, Daniel A. Waschbusch, PhD a, Tan Li, PhD c, Rebecca Marshall, MS d, Lysett Babocsai, PhD e, Hugh Humphery, MD d, Elizabeth Gnagy, MA f, James Swanson, PhD g, Tomasz Hanć, PhD h, Negar Fallahazad, BS c, William E. Pelham, PhD fAbstract |
Objective |
To examine the impact of central nervous system (CNS) stimulants on the growth of children with attention-deficit/hyperactivity disorder (ADHD), and to assess the efficacy and feasibility of weight recovery interventions on growth.
Method |
A total of 230 children aged 5 to 12 years with ADHD with no history of chronic CNS stimulant use were randomly assigned to receive daily CNS stimulants (78%, primarily osmotic release oral system-methylphenidate [OROS-MPH]) or behavioral treatment (22%) for 30 months. After 6 months, children evidencing a decline in body mass index (BMI) of >0.5 z-units were randomized to 1 of 3 weight recovery treatments (WRTs): monthly monitoring of height/weight (MON) plus continued daily medication; drug holidays (DH) with medication limited to school days; or daily caloric supplementation (CS) with a 150-kcal supplement plus daily medication.
Results |
Before WRT assignment, medication was associated with significant reductions in standardized weight and height (p values <.01). Adherence to CS and DH during WRT was high, with significant increases in daily caloric intake and decreases in weekly medication exposure (p values <.05). Across all WRT participants (n = 71), weight velocity increased significantly after WRT randomization (β2 = 0.271, SE = 0.027, p < .001).When analyzed by what parents did (versus what they were assigned to), CS (p < .01) and DH (p < .05) increased weight velocity more than MON. No increase in height velocity was seen after randomization to any WRT. Over the entire study, WRT participants declined in standardized weight (−0.44 z-units) and height (−0.20 z-units).
Conclusion |
Drug holidays, caloric supplementation, and increased monitoring all led to increased weight velocity in children taking CNS stimulants, but none led to increased height velocity.
Clinical trial registration information |
Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth; clinicaltrials.gov/; NCT01109849.
Le texte complet de cet article est disponible en PDF.Key words : attention-deficit/hyperactivity disorder, growth, CNS stimulants
Plan
| This trial was funded by the National Institute of Mental Health (NIMH; R01 MH083692). Funders had no role in the conduct of the research or preparation of the article. Authors also received support from the National Institute on Drug Abuse (NIDA; Pelham III: T32 DA039772; Pelham Jr: R01DA034731, MH101096), the National Institute on Alcohol Abuse and Alcoholism (NIAAA; Pelham III: F31 AA026768), the NIMH (Waxmonsky: MH80791; Pelham Jr: MH099030; Swanson: MH099030; Waschbusch: MH085796), the Institute of Education Sciences (IES; Pelham Jr: R324A180175, R305A170523) and Shire Pharmaceuticals (Waxmonsky and Waschbusch). Some study medication was donated by Janssen Pharmaceuticals. |
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| Dr. Li and Mr. Pelham III served as the statistical experts for this research. |
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| Disclosure: Dr. Waxmonsky has received research funding from National Institutes of Mental Health, Supernus, and Pfizer and has served on the advisory board for NLS Pharma and Purdue Pharma. Dr. Pelham has received funding from NIMH, NIAAA, NIDA, and the Institute of Education Sciences. Dr. Hanć has received travel support from MEDICE Arzneimittel Pütter GmbH and Co. KG. Drs. Campa, Waschbusch, Li, Babocsai, Humphery, and Swanson, Mr. Pelham, and Mss. Marshall, Gnagy, and Fallahazad have reported no biomedical financial interests or potential conflicts of interest. |
Vol 59 - N° 12
P. 1330-1341 - décembre 2020 Retour au numéro
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