Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00228046
Status:
COMPLETED
Last Update Posted:
2013-10-31
First Post:
2005-09-26
Brief Title:
Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder
Sponsor:
Stony Brook University
Organization:
Stony Brook University
Study Overview
Official Title:
Double-Blind Placebo-Controlled Trial of Flexible Dose Divalproex Sodium Adjunctive to Stimulant Treatment for Aggressive Children With Attention-Deficit Hyperactivity Disorder
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 assess whether adding a mood stabilizer divalproex sodium to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with attention deficit hyperactivity disorder ADHD
Detailed Description:
ADHD is one of the most common childhood mental disorders It often causes impaired functioning in multiple areas including home school and peer relationships Additionally children with ADHD often develop aggressive behavior which is not usually adequately suppressed by standard stimulant treatments for ADHD In order to address this problem many physicians prescribe multiple medications at once There is no clinical evidence however proving that this method is safe and effective This study will assess whether adding a mood stabilizer divalproex sodium to stimulant treatment is more effective than stimulant treatment alone in reducing aggressive behavior among children with ADHD
Participants in this double blind study will first receive open label stimulant treatment for ADHD and a comorbid disruptive behavior disorder Participants whose aggressive behavior subsides with stimulant treatment alone will not proceed into the next phase of the study Participants whose ADHD symptoms lessen from the treatment but whose aggressive behavior persists will be randomly assigned to receive either divalproex sodium or placebo in addition to their stimulant treatment for 8 weeks Study visits will be held weekly for 11 to 16 weeks At these visits aggression levels and medication side effects will be assessed Families will also meet with the researchers to discuss the childs progress and attend behavioral counseling with a therapist Participants who did not continue into the second phase of the study will be asked to return to the study site for a follow-up visit 8 weeks following the end of the first phase
Participants in this double blind study will first receive open label stimulant treatment for ADHD and a comorbid disruptive behavior disorder Participants whose aggressive behavior subsides with stimulant treatment alone will not proceed into the next phase of the study Participants whose ADHD symptoms lessen from the treatment but whose aggressive behavior persists will be randomly assigned to receive either divalproex sodium or placebo in addition to their stimulant treatment for 8 weeks Study visits will be held weekly for 11 to 16 weeks At these visits aggression levels and medication side effects will be assessed Families will also meet with the researchers to discuss the childs progress and attend behavioral counseling with a therapist Participants who did not continue into the second phase of the study will be asked to return to the study site for a follow-up visit 8 weeks following the end of the first phase
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 |
|---|---|---|---|
| DSIR CT-M1 | US NIH GrantContract | None | httpsreporternihgovquickSearchM01RR010710 |
| K23MH064975 | NIH | None | None |
| M01RR010710 | NIH | None | None |