Methylphenidate for Treating Children With ADHD and Tourette Syndrome

October 29, 2013 updated by: Stony Brook University

Methylphenidate Treatment of ADHD in Children With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

71

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

October 31, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH045358 (U.S. NIH Grant/Contract)
  • DDTR B2-NDH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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