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Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth

NCT01109849 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2017-07-14

Study results available
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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.

Conditions

  • ADHD
  • Growth

Interventions

BEHAVIORAL

behavior therapy

combination of individual and group parent training plus school consultation

DRUG

Extended release (ER) methylphenidate product

medication to be taken daily for duration of study unless assigned to weight promotion arm

OTHER

monitoring

monthly weight, height and BMI checks

OTHER

drug holiday

switch from seven day a week dosing to medication only on school days

DIETARY_SUPPLEMENT

caloric supplement

continue current ADHD regimen and add one 8oz liquid caloric supplement at night

Sponsors & Collaborators

  • Florida International University

    lead OTHER

Principal Investigators

  • James G Waxmonsky, MD · Florida International University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01109849 on ClinicalTrials.gov