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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Fluoxetine; Valproic Acid

Criteria

Inclusion Criteria:

• Diagnosis of Intermittent Explosive Disorder (IED)

• In good physical health

• Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening

• Willing and able to comply with the study requirements

Exclusion Criteria:

• Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation

• Current major depressive disorder, with a Hamilton Depression (HAM-D) Scale score higher than 18

• Current alcohol or drug abuse or dependence

• Active medical conditions that will interfere with the study

• Thymoleptic or neuroleptic treatments

• Presence of the following serious and active medical conditions: demyelinating or progressive degenerative disorders; central nervous system infection; progressive degenerative neurological disorder; ischemic heart disease; respiratory, renal, or liver disease; Type I diabetes; malignant neoplasm; hyper- or hypo-coagulopathy; Acquired Immune Deficiency Syndrome (AIDS); or seizure disorder. Participants with a history of more than two febrile seizures prior to 1 year of age are eligible.

• Chronic, ongoing treatment with the following classes of medications: antidepressants, neuroleptics, mood stabilizers, antianxiety agents, hypnotics, narcotics or synthetic narcotics, barbiturates, stimulants, anti-migraine agents, anti-epileptics, non-beta-blocking or Ca-channel blocking anti-arrhythmic agents prescribed to treat cardiac arrhythmia, anticoagulants, immunomodulators, anti-neoplastic agents, or HIV antiviral agents

• Ongoing psychotherapeutic treatment for the treatment of IED or anger that was started less than 3 months before study entry

• Hypersensitivity to fluoxetine or divalproex

• Pregnancy