Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078754
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2004-03-05
Brief Title:
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Fluoxetine and Divalproex Treatment Correlates in IED
Status:
COMPLETED
Status Verified Date:
2021-04
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:
This study will compare the medications fluoxetine Prozac and divalproex Depakote for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder IED
Detailed Description:
IED is a condition characterized by a failure to resist aggressive impulses IED is a behavioral defined condition for which effective treatments have not been identified Research suggests that serotonin 5-HT a chemical that helps regulate mood and emotions may play a role in the response to pharmacological IED treatments This study will examine the relationship between 5-HT receptors and response to treatment with fluoxetine or divalproex In addition this study will examine people with IED and those without the condition to determine whether there are differences in their 5-HT receptor and transporter systems
Participants in this study will be randomly assigned to receive either fluoxetine divalproex or placebo for 12 weeks Scale ratings will be used to assess the aggression levels of participants Biologic evaluations of the 5-HT system will be conducted throughout the study
Participants in this study will be randomly assigned to receive either fluoxetine divalproex or placebo for 12 weeks Scale ratings will be used to assess the aggression levels of participants Biologic evaluations of the 5-HT system will be conducted throughout 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 |
|---|---|---|---|
| R01MH066984 | NIH | None | None |
| DATR A5-ETMA | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH066984 |