Skip to main content
OpenTrials
Completed

NCT Number: NCT00441649

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug

Primary outcomes

  1. ADHD symptoms

  2. Oppositional and aggressive behavior

  3. Frequency and severity of tics and obsessive compulsive disorder symptoms

  4. Tic impairment, tic severity, and clinical response

  5. Anxiety and mood symptoms

  6. Rebound tic exacerbation

  7. Adverse drug reactions (all measured at 2-week intervals throughout the study)

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Methylphenidate Treatment of ADHD in Children With Tourette Syndrome

Important dates

Study start
2000
Primary completion
2004
Study completion
2007
First posted
Mar 1, 2007
Registry last updated
Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.