Methylphenidate for Treating Children With ADHD and Tourette Syndrome

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Stony Brook University
ClinicalTrials.gov Identifier:
NCT00441649
First received: February 28, 2007
Last updated: October 29, 2013
Last verified: October 2013
  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:


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

Publications:
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:
Syndrome
Hyperkinesis
Tourette Syndrome
Attention Deficit Disorder with Hyperactivity
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 18, 2014