Methylphenidate in Children and Adolescents With Pervasive Developmental Disorders

NCT ID: NCT00025779

Last Updated: 2009-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31

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).

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

methylphenidate

Intervention Type: DRUG

guanfacine

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: lead

Principal Investigators

Eugene Arnold, MD

Role: STUDY_CHAIR

Ohio State University

Larry Scahill, Ph.D

Role:

Yale University

Locations

UCLA Neuropsychiatric Institute

Los Angeles, California, United States

Yale Child Study Center

New Haven, Connecticut, United States

Indiana University-Riley Hospital for Children

Indianapolis, Indiana, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16926619 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17069547 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17276750 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17674186 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16275814 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Related Links

http://www.nimh.nih.gov/health/topics/child-and-adolescent-mental-health/index.shtml

More information on childhood disorders

Other Identifiers

N01 MH80011

Identifier Type: -

Identifier Source: secondary_id

N01 MH70010

Identifier Type: -

Identifier Source: secondary_id

N01 MH70001

Identifier Type: -

Identifier Source: secondary_id

DSIR CT

Identifier Type: -

Identifier Source: secondary_id

N01 MH70009

Identifier Type: -

Identifier Source: org_study_id