Methylphenidate for Treating Children With ADHD and Tourette Syndrome

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Methylphenidate Treatment of ADHD in Children With Tourette Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441649
• Other study ID #: R01MH045358
• Secondary ID: R01MH045358DDTR
• Status: Completed
• Phase: N/A
• First received: February 28, 2007
• Last updated: October 29, 2013
• Start date: February 2000
• Est. completion date: January 2007

Study information

• Verified date: October 2013
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: January 2007
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Syndrome
• Tourette Syndrome

Intervention

Drug:
• Methylphenidate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	National Institute of Mental Health (NIMH)

References & Publications (2)

Gadow KD, Sverd J, Sprafkin J, Nolan EE, Ezor SN. Efficacy of methylphenidate for attention-deficit hyperactivity disorder in children with tic disorder. Arch Gen Psychiatry. 1995 Jun;52(6):444-55. Erratum in: Arch Gen Psychiatry 1995 Oct;52(10):836. — View Citation

Gadow KD, Sverd J, Sprafkin J, Nolan EE, Grossman S. Long-term methylphenidate therapy in children with comorbid attention-deficit hyperactivity disorder and chronic multiple tic disorder. Arch Gen Psychiatry. 1999 Apr;56(4):330-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD symptoms
Primary	Oppositional and aggressive behavior
Primary	Frequency and severity of tics and obsessive compulsive disorder symptoms
Primary	Tic impairment, tic severity, and clinical response
Primary	Anxiety and mood symptoms
Primary	Rebound tic exacerbation
Primary	Adverse drug reactions (all measured at 2-week intervals throughout the study)