Attention Deficit Hyperactivity Disorder Clinical Trial
Official title:
Developing More Efficacious Treatments for Children With ADHD Who Are "Partial" or "Non-responders" to Stimulants
The purpose of this pilot is to initiate a program of research into the development of effective medication techniques to treat those children with ADHD who are referred because they are "partial" or "non-responders" to standard stimulant treatment.
We propose to do this with a single site, ten week, pilot study of 40 school age children,
ages 6-17, with Attention-Deficit/ Hyperactivity Disorder (ADHD) and moderate or greater
impairment (C-GAS < 55) who show ADHD symptoms despite a trial in the community with their
primary care practitioner with either of two of the most commonly used stimulants (i.e.,
either OROS-MPH (Concerta) or mixed salts of amphetamine (Adderall-XR)).
These children first will be classified into three groups: Group 1, those who had been
treated with a maximal dose of stimulant with partial or no response; Group 2, those treated
with a suboptimal dose of stimulant and showing partial or no response, and Group 3, those
who developed side effects that limited continued treatment with optimal doses of a
stimulant.
The next step will be to enter these children into an open, two week trial to confirm their
treatment resistance. Group 2, those treated with suboptimal doses, will have the dosage
increased to the maximum recommended stimulant dose. Group 1, those who had been treated for
4 weeks with maximal doses of a stimulant, or Group 3, those who developed moderate to severe
drug-related side effects, will be switched to the other class of stimulant for a two week
trial, unless they have been tried on both classes. Those children will be maintained on
their current class of stimulant for two weeks. At the end of the two weeks, all children
will be rated on the ADHD-IV-RS by the Study Doctor. Those who have shown moderate to severe
side effects or those who respond will exit the trial and be treated openly. Children from
Group 2 who continue to show no improvement after a week will switch to the other stimulant.
All children from Group 2 tried on both stimulants and all children from Groups 1 and 3 who
continue to show mean scores greater than 1 SD over the mean for age will be referred to
Phase 2.
During phase 2, they will be randomized to one of two treatment arms for eight weeks. The
first treatment arm, the "simple treatment" arm, will consist of parent training plus
continued treatment with a stimulant that is tolerated but has not yet decreased ADHD
symptoms enough to meet our criterion of response, plus a placebo matching aripiprazole. The
second treatment arm, called the "combination" arm, will consist of parent training plus
continued treatment on stimulant plus augmentation with a second generation antipsychotic
(aripiprazole). Aripiprazole (Abilify™ ) is a product that is FDA-approved and marketed for
the treatment of schizophrenia and for the treatment of acute manic episodes associated with
Bipolar I Disorder in adults only. However, aripiprazole is also used to treat children and
adolescents with aggressive and oppositional disorders in standard clinical practice. We will
continue randomizing patients until we have 40 children with ADHD become eligible to enter
Phase 2.
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