Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders
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Purpose
| 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 (Child) |
| 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 |
| OverallOfficial: | Larry Scahill, Ph.D | Yale University |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00025779 History of Changes |
| Other Study ID Numbers: | N01MH70009 N01MH80011 N01MH70010 N01MH70001 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:
|
Disease Attention Deficit Disorder with Hyperactivity Hyperkinesis Autistic Disorder Developmental Disabilities Autism Spectrum Disorder Child Development Disorders, Pervasive Pathologic Processes Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Methylphenidate Guanfacine Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents |
ClinicalTrials.gov processed this record on September 23, 2016