Methylphenidate for Treating Children With ADHD and Tourette Syndrome - Full Text View

Purpose

This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder in children with both attention deficit hyperactivity disorder and Tourette syndrome.

Condition	Intervention
Attention Deficit Disorder With Hyperactivity Tourette Syndrome	Drug: Methylphenidate


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Methylphenidate Treatment of ADHD in Children With Tourette Syndrome

Resource links provided by NLM:

Genetics Home Reference related topics: Tourette syndrome

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Tourette Syndrome

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Stony Brook University:

Primary Outcome Measures:

ADHD symptoms
Oppositional and aggressive behavior
Frequency and severity of tics and obsessive compulsive disorder symptoms
Tic impairment, tic severity, and clinical response
Anxiety and mood symptoms
Rebound tic exacerbation
Adverse drug reactions (all measured at 2-week intervals throughout the study)


Estimated Enrollment:	71
Study Start Date:	February 2000
Study Completion Date:	January 2007
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Detailed Description:

Tourette syndrome is a neurological disorder that is characterized by repetitive, involuntary movements and vocalizations called tics. Many children with Tourette syndrome also have attention deficit hyperactivity disorder (ADHD), which is one of the most common childhood mental disorders. Symptoms of ADHD usually include impulsiveness, inattention, and hyperactivity. ADHD is commonly treated with a stimulant medication, such as methylphenidate. It is under debate, however, whether using stimulants in children with Tourette syndrome exacerbates tics associated with the disorder. This study will evaluate the safety and effectiveness of methylphenidate in treating ADHD in children who have both ADHD and Tourette syndrome.

Participants in this 6-week, double blind study will receive three doses of methylphenidate over the course of the study. Each dose will be taken twice daily, approximately 3.5 hours apart, for 2 weeks. Medication will be dispensed at study visits, which will occur once every 2 weeks. At each study visit, participants will take a dose of the medication. About an hour after ingesting the medication, they will be observed in a classroom setting by study physicians. Participants will then complete a Continuous Performance Test, which will measure their voluntary attention levels. The following will be assessed at study visits: ADHD symptoms; oppositional and aggressive behavior; frequency and severity of tics and obsessive compulsive disorder symptoms; rebound tic exacerbation; effects of methylphenidate on tic-related problems with self-esteem, family life, academic and social performance, and overall tic severity; anxiety and mood symptoms; and adverse drug reactions. Parents and teachers will also complete assessments of participants' behavior on 2 days of each week for the duration of the study.

Eligibility


Ages Eligible for Study:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of ADHD or ADHD plus Tourette syndrome

Exclusion Criteria:

Determined to be dangerous to self or others
Scores less than 70 on an IQ test
Any seizure disorder, major organic brain dysfunction, major medical illness, major mood disorder, psychosis, pervasive developmental disorder, or peripheral sensory loss
Any condition that may make use of methylphenidate unsafe

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441649

Sponsors and Collaborators

Stony Brook University

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Kenneth D. Gadow, PhD	State University of New York at Stony Brook

More Information

Publications:

Gadow KD, Sverd J, Sprafkin J, Nolan EE, Ezor SN. Efficacy of methylphenidate for attention-deficit hyperactivity disorder in children with tic disorder. Arch Gen Psychiatry. 1995 Jun;52(6):444-55. Erratum in: Arch Gen Psychiatry 1995 Oct;52(10):836.

Gadow KD, Sverd J, Sprafkin J, Nolan EE, Grossman S. Long-term methylphenidate therapy in children with comorbid attention-deficit hyperactivity disorder and chronic multiple tic disorder. Arch Gen Psychiatry. 1999 Apr;56(4):330-6.


ClinicalTrials.gov Identifier:	NCT00441649 History of Changes
Other Study ID Numbers:	R01 MH45358, R01MH045358, DDTR B2-NDH
Study First Received:	February 28, 2007
Last Updated:	October 29, 2013
Health Authority:	United States: Federal Government

Keywords provided by Stony Brook University:


ADHD

Additional relevant MeSH terms:


Tourette Syndrome Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Mental Disorders Diagnosed in Childhood Movement Disorders Nervous System Diseases Neurodegenerative Diseases	Tic Disorders Methylphenidate Central Nervous System Agents Central Nervous System Stimulants Dopamine Agents Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015