Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders
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| ClinicalTrials.gov Identifier: NCT00025779 |
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Recruitment Status :
Completed
First Posted : October 24, 2001
Last Update Posted : July 28, 2009
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Attention Deficit Disorder With Hyperactivity Autistic Disorder Pervasive Development Disorders | Drug: methylphenidate Drug: guanfacine | Not Applicable |
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 No participant will be withdrawn from a currently effective medication.
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 60 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | Methylphenidate for Hyperactivity and Impulsiveness in Children and Adolescents With Pervasive Developmental Disorders |
| Study Start Date : | October 2001 |
| Actual Primary Completion Date : | November 2003 |
- hyperactivity, impulsiveness, and distractibility
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| Ages Eligible for Study: | 5 Years to 14 Years (Child) |
| Sexes Eligible for Study: | All |
| 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Publications of Results:
Other Publications:
| ClinicalTrials.gov Identifier: | NCT00025779 |
| Other Study ID Numbers: |
N01 MH70009 N01 MH80011 N01 MH70010 N01 MH70001 DSIR CT |
| First Posted: | October 24, 2001 Key Record Dates |
| Last Update Posted: | July 28, 2009 |
| Last Verified: | August 2008 |
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Hyperactivity Distractibility Impulsiveness Pervasive Development Disorders |
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Hyperkinesis Disease Attention Deficit Disorder with Hyperactivity 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 Guanfacine |
Methylphenidate 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 |