Examining Tolerance to CNS Stimulants in ADHD
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 6 - 12 |
| Updated: | 7/11/2018 |
| Start Date: | April 2013 |
| End Date: | March 2020 |
Although stimulant medication is a well-established treatment for ADHD, it is often necessary
for doctors to increase the dose over time to maintain the benefits of the medication. While
medication can be very effective for improving symptoms of ADHD during the first year of use,
it has not been found to significantly improve the long term course of children with ADHD.
For example, in large research studies, groups of children who take medication for ten years
do not have consistently better academic grades than groups of children who never used
medication (individual results will vary from child to child).
In order to help children with ADHD achieve the best possible outcomes, it is important for
doctors to study why this happens. One possible reason is development of tolerance to the
medication. Tolerance means that a drug's effects decrease when it is taken consistently over
time, so that an increased dose is needed to continue showing effects. Some doctors believe
that children who take stimulant medication for ADHD develop tolerance to it which would
explain why benefits may not persist over time, but no research studies have been done to
measure whether this occurs. This study aims to see if children show a tolerance effect to
stimulant medication and whether that tolerance can be prevented by taking short breaks from
the medication called medication holidays.
for doctors to increase the dose over time to maintain the benefits of the medication. While
medication can be very effective for improving symptoms of ADHD during the first year of use,
it has not been found to significantly improve the long term course of children with ADHD.
For example, in large research studies, groups of children who take medication for ten years
do not have consistently better academic grades than groups of children who never used
medication (individual results will vary from child to child).
In order to help children with ADHD achieve the best possible outcomes, it is important for
doctors to study why this happens. One possible reason is development of tolerance to the
medication. Tolerance means that a drug's effects decrease when it is taken consistently over
time, so that an increased dose is needed to continue showing effects. Some doctors believe
that children who take stimulant medication for ADHD develop tolerance to it which would
explain why benefits may not persist over time, but no research studies have been done to
measure whether this occurs. This study aims to see if children show a tolerance effect to
stimulant medication and whether that tolerance can be prevented by taking short breaks from
the medication called medication holidays.
This is an innovative evaluation of tolerance using an objective measure in an analog
classroom. Each subject will complete the a 10-minute math test twice a day for three weeks
on optimal dose or placebo, and then be crossed over to the other condition. Within-subject
drug/placebo differences will be compared over the three weeks of exposure to assess
tolerance in the analog setting.
When school commences, 50% of the sample will be randomized to 7-day-a-week (continuous)
dosing and 50% to 5-day-a- week (weekend holidays) dosing to examine the efficacy of
prescribed weekend drug holidays for combatting need for dose escalations (tolerance) during
the school year.
Participants will be assessed monthly to detect deteriorating functioning. Using a
standardized protocol, study physicians will increase dose for subjects in either arm who
meet defined impairment thresholds. The difference between the two dosing conditions will
inform regarding how best to deal with tolerance in clinical application.
classroom. Each subject will complete the a 10-minute math test twice a day for three weeks
on optimal dose or placebo, and then be crossed over to the other condition. Within-subject
drug/placebo differences will be compared over the three weeks of exposure to assess
tolerance in the analog setting.
When school commences, 50% of the sample will be randomized to 7-day-a-week (continuous)
dosing and 50% to 5-day-a- week (weekend holidays) dosing to examine the efficacy of
prescribed weekend drug holidays for combatting need for dose escalations (tolerance) during
the school year.
Participants will be assessed monthly to detect deteriorating functioning. Using a
standardized protocol, study physicians will increase dose for subjects in either arm who
meet defined impairment thresholds. The difference between the two dosing conditions will
inform regarding how best to deal with tolerance in clinical application.
Inclusion Criteria:
- Diagnosis of attention-deficit/hyperactivity disorder
- Full Scale IQ above 80
Exclusion Criteria:
- Psychotropic medications for conditions other than ADHD
- Active medical or psychiatric conditions that could be worsened by stimulants
- Diagnosis of Autism or Asperger's Disorder
- Documented intolerance fo methylphenidate or failed trial of OROS MPH
We found this trial at
1
site
Miami, Florida 33199
Principal Investigator: William E Pelham, Ph.D.
Phone: 305-348-0477
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