NCT00078754

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

Fluoxetine and Divalproex: Treatment Correlates in IED

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intermittent Explosive Disorder

Interventions

Type	Name	Description
DRUG	Fluoxetine	Fluoxetine capsules by mouth, up to 60 mg daily
DRUG	Divalproex	Divalproex ER capsules by mouth, up to 3000 mg daily
DRUG	Placebo	Placebo capsules by mouth, up to 8 capsules daily

Timeline

• Start date: 2003-05-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2004-03-08
• Last updated: 2021-04-27
• Results posted: 2014-12-31

Locations

1 site across 1 country: United States