Methylphenidate for Treating Children With ADHD and Tourette Syndrome
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| ClinicalTrials.gov Identifier: NCT00441649 |
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Recruitment Status :
Completed
First Posted : March 1, 2007
Last Update Posted : October 31, 2013
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Attention Deficit Disorder With Hyperactivity Tourette Syndrome | Drug: Methylphenidate | Not Applicable |
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 (Clinical Trial) |
| Enrollment : | 71 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | Methylphenidate Treatment of ADHD in Children With Tourette Syndrome |
| Study Start Date : | February 2000 |
| Actual Primary Completion Date : | June 2004 |
| Actual Study Completion Date : | January 2007 |
- 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)
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| Ages Eligible for Study: | 6 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00441649
| Principal Investigator: | Kenneth D. Gadow, PhD | State University of New York at Stony Brook |
Publications:
| ClinicalTrials.gov Identifier: | NCT00441649 History of Changes |
| Other Study ID Numbers: |
R01MH045358 ( U.S. NIH Grant/Contract ) R01MH045358 ( U.S. NIH Grant/Contract ) DDTR B2-NDH |
| First Posted: | March 1, 2007 Key Record Dates |
| Last Update Posted: | October 31, 2013 |
| Last Verified: | October 2013 |
Keywords provided by Stony Brook University:
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ADHD |
Additional relevant MeSH terms:
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Tourette Syndrome Syndrome Attention Deficit Disorder with Hyperactivity Disease Pathologic Processes Attention Deficit and Disruptive Behavior Disorders Neurodevelopmental Disorders Mental Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Tic Disorders |
Movement Disorders Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Methylphenidate Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents |