Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders
Condition: Attention Deficit Disorder With Hyperactivity; Autistic Disorder; Pervasive Development Disorders
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Autistic Disorder; Developmental Disabilities; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): methylphenidate; guanfacine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Guanfacine; Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hyperactivity; Distractibility; Impulsiveness; Pervasive Development Disorders