A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Completed · Phase 2 · Has a placebo group
Conditions studied: Intermittent Explosive Disorder
In brief
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
Key facts
- Study ID
- NCT00078754
- Run by
- University of Chicago
- People needed
- 90
- Starts
- 2003-05-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2021-04-27
Who can join
Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- The University of Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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