Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Attention Deficit Disorder With Hyperactivity Autistic Disorder Pervasive Development Disorders |
Drug: methylphenidate Drug: guanfacine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders |
- hyperactivity, impulsiveness, and distractibility
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2001 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 5 Years to 14 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00025779
| United States, California | |
| UCLA Neuropsychiatric Institute | |
| Los Angeles, California, United States, 90024 | |
| United States, Connecticut | |
| Yale Child Study Center | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Indiana | |
| Indiana University-Riley Hospital for Children | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Maryland | |
| Kennedy Krieger Institute | |
| Baltimore, Maryland, United States, 21231 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Study Chair: | Eugene Arnold, MD | Ohio State University | |
| Investigator: | Larry Scahill, Ph.D | Yale University |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00025779 History of Changes |
| Other Study ID Numbers: | N01 MH70009, N01 MH80011, N01 MH70010, N01 MH70001, DSIR CT |
| Study First Received: | October 23, 2001 |
| Last Updated: | July 24, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Hyperactivity Distractibility Impulsiveness Pervasive Development Disorders |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Autistic Disorder Child Development Disorders, Pervasive Developmental Disabilities Disease Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Dyskinesias Mental Disorders Mental Disorders Diagnosed in Childhood Nervous System Diseases Neurologic Manifestations Pathologic Processes |
Signs and Symptoms Methylphenidate Central Nervous System Agents Central Nervous System Stimulants Dopamine Agents Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015