|
Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders Clinical research trials and Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders. Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders  Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders
Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders
For Condition: Pervasive Development Disorders,Attention Deficit Disorder with Hyperactivity,Autistic Disorder
Status: No longer recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: 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).
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Dose Comparison, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 5 Years/14 Years
Genders: Both
Protocol Entry Criteria: - Diagnosis of PDD (including Asperger's Disorder and Autistic Disorder) - Clinically significant symptoms of ADHD - Mental age of at least 18 months - Blood pressure within normal ranges for age and gender - Weight 16 kg or more - Absence of chronic tic disorder - Absence of any medical condition that would be incompatible with the study treatments - Absence of evidence of hypersensitivity to study treatments
Total Enrollment: 60
Location and Contact Information:
Overall Study Official:
LarryScahill, , Yale University
Indiana University-Riley Hospital for Children
Indianapolis, Indiana, 46202
United States
Kennedy Krieger Institute
Baltimore, Maryland, 21231
United States
Yale Child Study Center
New Haven, Connecticut, 06520
United States
UCLA Neuropsychiatric Institute
Los Angeles, California, 90024
United States
Ohio State University
Columbus, Ohio, 43210
United States
Additional Information:
Study ID Numbers: N01MH70009-A; N01MH80011-A,N01MH70001-A,N01MH70010-A
Study Start Date: October 2001
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025779
Other Pervasive Development Disorders Studies:
1. Drug Treatment for Autism
2. A Controlled Study of Olanzapine in Children with Autism
3. RUPP PI PDD: Drug and Behavioral Therapy for Children with Pervasive Developmental Disorders
4. Treatment of Autism in Children and Adolescents
5. Study of Fluoxetine in Adults With Autistic Disorder
Related Studies:
Other Pervasive Development Disorders Clinical Trials
Other Indiana Clinical Trials
Other Indianapolis Clinical Trials
Methylphenidate in Children and Adolescents with Pervasive Developmental Disorders
|
|
|
|
|
|
|
|
