Conditions: Intermittent Explosive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 90
Healthy volunteers: no

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.

Arms:
arm 1: Participants will to receive treatment with fluoxetine for 12 weeks arm 2: Participants will to receive treatment with divalproex for 12 weeks arm 3: Participants will to receive treatment with placebo for 12 weeks

Interventions: intervention 1: Fluoxetine intervention 2: Divalproex intervention 3: Placebo
Intervention descriptions: intervention 1: Fluoxetine capsules by mouth, up to 60 mg daily intervention 2: Divalproex ER capsules by mouth, up to 3000 mg daily intervention 3: Placebo capsules by mouth, up to 8 capsules daily

Protocol document: