Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00218114
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2005-09-16
Brief Title:
Divalproex Sodium Depakote for Explosive Tempers in Adolescents and Adults
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Parallel Groups Study of Divalproex Sodium Depakote for Irritable Explosive Adults Adolescents
Status:
COMPLETED
Status Verified Date:
2017-08
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 compare the effectiveness of divalproex sodium Depakote versus placebo in treating disruptive behavior disorder and explosive tempers in adolescents and adults
Detailed Description:
Disruptive behavior disorders among children and adolescents are readily diagnosed however few individuals with such disorders receive drug treatment Depakote is a mood stabilizing medication that may be beneficial in treating individuals with disruptive behavior disorders The purpose of this study is to examine the effectiveness of Depakote in reducing temper outbursts and improving mood in individuals with disruptive behavior disorders In addition this study will determine the safety and effectiveness of Depakote in treating individuals with substance disorders who also have disruptive behavior disorders
This study will last 6 weeks Participants will be randomly assigned to receive treatment with Depakote or placebo Medication will be given in a single evening dose if tolerated otherwise medication will be given twice per day Participants will be assigned to a fixed-flexible dosing schedule and dosages will increase based on weight All participants will attend weekly psychotherapy and family counseling sessions throughout the study Participants who are substance abusers will also receive substance abuse counseling Weekly study visits will include a physical exam blood collection and drug tests Teachers and guidance counselors will be contacted to assess the participants behavior from week to week Some participants will complete a follow-up study in which they will take part in phone interviews
This study will last 6 weeks Participants will be randomly assigned to receive treatment with Depakote or placebo Medication will be given in a single evening dose if tolerated otherwise medication will be given twice per day Participants will be assigned to a fixed-flexible dosing schedule and dosages will increase based on weight All participants will attend weekly psychotherapy and family counseling sessions throughout the study Participants who are substance abusers will also receive substance abuse counseling Weekly study visits will include a physical exam blood collection and drug tests Teachers and guidance counselors will be contacted to assess the participants behavior from week to week Some participants will complete a follow-up study in which they will take part in phone interviews
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 |
|---|---|---|---|
| R01DA012234 | NIH | None | httpsreporternihgovquickSearchR01DA012234 |