Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441649
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2007-02-28
Brief Title:
Methylphenidate for Treating Children With ADHD and Tourette Syndrome
Sponsor:
Stony Brook University
Organization:
Stony Brook University
Study Overview
Official Title:
Methylphenidate Treatment of ADHD in Children With Tourette Syndrome
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 35 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
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 35 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DDTR B2-NDH | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH045358 |
| R01MH045358 | NIH | None | None |