Attention Deficit Disorder With Hyperactivity Clinical Trial
Official title:
Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders
This study will evaluate the efficacy and safety of methylphenidate for treating hyperactivity, impulsiveness, and distractibility in 60 children and adolescents with Pervasive Developmental Disorders (PDD). Methylphenidate (Ritalin)is approved by the Food and Drug Administration for the treatment of children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD). Data supporting its safety and effectiveness in treating ADHD symptoms in PDD are limited. Children and adolescents who do not show a positive response to methylphenidate will be invited to participate in a pilot study of the non-stimulant medication guanfacine (Tenex).
The safety and efficacy of methylphenidate (MPH) in 60 children and adolescents with PDD and
behavioral difficulties (such as hyperactivity, impulsiveness and distractibility) will be
evaluated in a multi-dose, 4-week randomized, crossover, placebo-controlled study. The MPH
study has three parts: a Test-Dose Period, a Double-Blind trial and an 8-Week Extension
Period (open-label). After a screening visit, eligible children will start a 1-week
Test-Dose Period. During this week, each child will be given the three MPH doses that are
used in the Double-Blind trial to make sure there are no serious side effects. If problems
are encountered at the high dose level, that dose will not be given in the Double-Blind
phase. The Double-Blind phase lasts 4 weeks and consists of three different MPH dose levels
and a week of placebo. Each treatment/dose is given for 1 week, and neither the researcher
nor the participants' families will know whether the medication is placebo or MPH. Children
who do well during this phase will continue on the best dose of MPH (determined during the
Double-Blind phase) for an additional eight weeks (open-label).
Those who do not show significant improvement during the Double-Blind phase, do not tolerate
MPH during the Test Dose Period, or are not able to take MPH before beginning the study are
offered open-label treatment with guanfacine for 8 weeks.
Prior to randomization in the MPH trial OR entry into the open-label guanfacine trial, there
will be a medication-free period for children who are currently on medication. The
withdrawal will be conducted in clinically appropriate way (depending on drug and duration
of treatment) to minimize withdrawal effects. This period is to establish a drug-free
baseline measurement and to minimize drug-drug interaction. No participant will be withdrawn
from a currently effective medication.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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