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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH045358 | U.S. NIH Grant/Contract | View source | |
| DDTR B2-NDH |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth D. Gadow, PhD | State University of New York at Stony Brook | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7771914 | Background | 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. doi: 10.1001/archpsyc.1995.03950180030005. | |
| 10197827 | Background | 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. doi: 10.1001/archpsyc.56.4.330. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001480 | Basal Ganglia Diseases |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |