Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

NCT00025779 | Completed

• 5 other identifiers: N01 MH70009N01 MH80011N01 MH70010N01 MH70001DSIR CT
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

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).

Conditions

Attention Deficit Disorder With Hyperactivity; Autistic Disorder; Pervasive Development Disorders

Keywords

Hyperactivity; Distractibility; Impulsiveness; Pervasive Development Disorders

Outcome Measures

Primary Outcomes (1)

• hyperactivity, impulsiveness, and distractibility

Interventions

methylphenidate DRUG

guanfacine DRUG

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (5)

UCLA Neuropsychiatric Institute

Los Angeles, California, 90024, United States

Location

Yale Child Study Center

New Haven, Connecticut, 06520, United States

Location

Indiana University-Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, 21231, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (6)

• 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. doi: 10.1097/01.chi.0000220854.79144.e7.

  PMID: 16926619 BACKGROUND

• 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. doi: 10.1089/cap.2006.16.589.

  PMID: 17069547 BACKGROUND

• 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. doi: 10.1016/j.biopsych.2006.09.028.

  PMID: 17276750 BACKGROUND

• 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. doi: 10.1007/s10802-007-9165-9. Epub 2007 Aug 3.

  PMID: 17674186 BACKGROUND

• 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. doi: 10.1001/archpsyc.62.11.1266.

  PMID: 16275814 RESULT

• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

  PMID: 37811711 DERIVED

Related Links

• More information on childhood disorders

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autistic Disorder; Child Development Disorders, Pervasive; Spasm; Impulsive Behavior

Interventions

Methylphenidate; Guanfacine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Autism Spectrum Disorder; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Guanidines; Amidines

Study Officials

• Eugene Arnold, MD

  Ohio State University

  STUDY CHAIR

• Larry Scahill, Ph.D

  Yale University

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 23, 2001
• First Posted: October 24, 2001
• Study Start: October 1, 2001
• Primary Completion: November 1, 2003
• Last Updated: July 28, 2009

Record last verified: 2008-08

Locations

US (5)