Clinical Trial: A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Fluoxetine and Divalproex: Treatment Correlates in IED

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 Summary:

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.


Sponsor: University of Chicago

Current Primary Outcome: Overt Aggression Scale-Modified (OAS-M) [ Time Frame: Measured at Week 12 ]

OAS-M is a validated instrument that measures aggression. Anti-aggressive effect of the drug/placebo was measured by the aggression score from OAS-M. Possible scores for aggression range from 0 (no aggression) to infinity (because the score is calculated by the number of times an aggressive behavior occurred, which theoretically has no possible maximum). Therefore the bigger number, the worse anti-aggression effect, thus the worse outcome. In each weekly visit, OAS-M score was calculated for the past week.


Original Primary Outcome:

Current Secondary Outcome: Treatment Response, Assessed as a Function of the Severity of Lifetime Aggressiveness of the Participant and as a Function of the Pretreatment Status of the Central 5-HT Receptor System [ Time Frame: Measured at Week 12 ]

Original Secondary Outcome:

Information By: University of Chicago

Dates:
Date Received: March 5, 2004
Date Started: May 2003
Date Completion:
Last Updated: December 29, 2014
Last Verified: December 2014