Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth
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| City: |
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Miami |
| State: |
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Florida |
| Zip Code: |
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33199 |
| Conditions: |
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ADHD - Growth |
| Purpose: |
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Previous NIH funded 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.
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| Study Summary: |
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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 3 for
medication and month 6 for behavior therapy (because it can take longer for behavior
therapy to work), 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.
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| Criteria: |
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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 IQ 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.
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| NCT ID: |
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NCT01109849 |
| Primary Contact: |
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Principal Investigator
James G Waxmonsky, MD
Florida International University
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| Backup Contact: |
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N/A |
| Location Contact: |
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Miami, Florida 33199
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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