Status:
COMPLETED
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Intermittent Explosive Disorder
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
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 serot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00078754
Start Date
May 1 2003
End Date
October 1 2008
Last Update
April 27 2021
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637