Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217932
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2005-09-16
Brief Title:
Effectiveness of Divalproex Sodium Depakote in Treating Children With Temper Outbursts and Severe Mood Swings
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Double-Blind Placebo-Controlled Study of Depakote Divalproex Sodium in Children With Temper Outbursts and Severe Mood Swings
Status:
COMPLETED
Status Verified Date:
2006-04
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:
The purpose of this study is to determine the effectiveness of divalproex sodium Depakote versus placebo in treating children with temper outbursts and severe mood disorders
Detailed Description:
Depakote has been used to treat seizures in children for more than 20 years The purpose of this study is to determine the effectiveness of divalproex sodium Depakote in treating children with temper outbursts and severe mood disorders
This study will last 12 weeks Participants will be randomly assigned to receive either 250 mg Depakote or placebo The dose of medication will increase at the end of Week 1 to 500 mg of either depakote or placebo participants will remain on this dose through Week 5 At Week 6 participants will cross-over and receive the other treatment either depakote or placebo which they will take through Week 12 Study visits will occur weekly and will include a physical exam blood and urine tests and self-reports of adverse events In addition caregivers will complete reports about mood swings throughout the study
This study will last 12 weeks Participants will be randomly assigned to receive either 250 mg Depakote or placebo The dose of medication will increase at the end of Week 1 to 500 mg of either depakote or placebo participants will remain on this dose through Week 5 At Week 6 participants will cross-over and receive the other treatment either depakote or placebo which they will take through Week 12 Study visits will occur weekly and will include a physical exam blood and urine tests and self-reports of adverse events In addition caregivers will complete reports about mood swings throughout the study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMC | None | None | None |
| K02-00451-1 | None | None | None |