Brief Title
Methylphenidate for Treating Children With ADHD and Tourette Syndrome
Official Title
Methylphenidate Treatment of ADHD in Children With Tourette Syndrome
Brief Summary
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.
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.
Study Type
Interventional
Primary Outcome
ADHD symptoms
Condition
Attention Deficit Disorder With Hyperactivity
Intervention
Methylphenidate
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
71
Start Date
February 2000
Completion Date
January 2007
Primary Completion Date
June 2004
Eligibility 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
Gender
All
Ages
6 Years - 12 Years
Accepts Healthy Volunteers
No
Contacts
Kenneth D. Gadow, PhD, ,
Administrative Informations
NCT ID
NCT00441649
Organization ID
R01MH045358
Secondary IDs
R01MH045358
Study Sponsor
Stony Brook University
Collaborators
National Institute of Mental Health (NIMH)
Study Sponsor
Kenneth D. Gadow, PhD, Principal Investigator, State University of New York at Stony Brook
Verification Date
October 2013