Methylphenidate for Treating Children With ADHD and Tourette Syndrome

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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