Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

• ClinicalTrials.gov Identifier: NCT00025779
• Recruitment Status: Completed
• First Posted: October 24, 2001
• Last Update Posted: July 28, 2009
• Sponsor: National Institute of Mental Health (NIMH)
• Information provided by: National Institute of Mental Health (NIMH)

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Attention Deficit Disorder With Hyperactivity; Autistic Disorder; Pervasive Development Disorders	Drug: methylphenidate; Drug: guanfacine	Not Applicable

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.

Study Design

• 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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. hyperactivity, impulsiveness, and distractibility

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 14 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

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

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

• Study Chair: Eugene Arnold, MD; Ohio State University
• OverallOfficial: Larry Scahill, Ph.D; Yale University

More Information

Additional Information:

More information on childhood disorders 

Publications of Results:

Research Units on Pediatric Psychopharmacology Autism Network. Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity. Arch Gen Psychiatry. 2005 Nov;62(11):1266-74.

Other Publications:

Scahill L, McDougle CJ, Williams SK, Dimitropoulos A, Aman MG, McCracken JT, Tierney E, Arnold LE, Cronin P, Grados M, Ghuman J, Koenig K, Lam KS, McGough J, Posey DJ, Ritz L, Swiezy NB, Vitiello B; Research Units on Pediatric Psychopharmacology Autism Network. Children's Yale-Brown Obsessive Compulsive Scale modified for pervasive developmental disorders. J Am Acad Child Adolesc Psychiatry. 2006 Sep;45(9):1114-23.

Scahill L, Aman MG, McDougle CJ, McCracken JT, Tierney E, Dziura J, Arnold LE, Posey D, Young C, Shah B, Ghuman J, Ritz L, Vitiello B. A prospective open trial of guanfacine in children with pervasive developmental disorders. J Child Adolesc Psychopharmacol. 2006 Oct;16(5):589-98.

Posey DJ, Aman MG, McCracken JT, Scahill L, Tierney E, Arnold LE, Vitiello B, Chuang SZ, Davies M, Ramadan Y, Witwer AN, Swiezy NB, Cronin P, Shah B, Carroll DH, Young C, Wheeler C, McDougle CJ. Positive effects of methylphenidate on inattention and hyperactivity in pervasive developmental disorders: an analysis of secondary measures. Biol Psychiatry. 2007 Feb 15;61(4):538-44.

Sukhodolsky DG, Scahill L, Gadow KD, Arnold LE, Aman MG, McDougle CJ, McCracken JT, Tierney E, Williams White S, Lecavalier L, Vitiello B. Parent-rated anxiety symptoms in children with pervasive developmental disorders: frequency and association with core autism symptoms and cognitive functioning. J Abnorm Child Psychol. 2008 Jan;36(1):117-28. Epub 2007 Aug 3.

• ClinicalTrials.gov Identifier: NCT00025779 History of Changes
• Other Study ID Numbers: N01 MH70009; N01 MH80011; N01 MH70010; N01 MH70001; DSIR CT
• First Posted: October 24, 2001
• Last Update Posted: July 28, 2009
• Last Verified: August 2008

Keywords provided by National Institute of Mental Health (NIMH):

Hyperactivity; Distractibility; Impulsiveness; Pervasive Development Disorders

Additional relevant MeSH terms:

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; Signs and Symptoms; 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