Methylphenidate for Treating Children With ADHD and Tourette Syndrome
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.
Attention Deficit Disorder With Hyperactivity
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Methylphenidate Treatment of ADHD in Children With Tourette Syndrome|
- 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)
|Study Start Date:||February 2000|
|Study Completion Date:||January 2007|
|Primary Completion Date:||June 2004 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441649
|Principal Investigator:||Kenneth D. Gadow, PhD||State University of New York at Stony Brook|