A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder (NCT00078754) | Clinical Trial Compass
CompletedPhase 2
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
United States90 participantsStarted 2003-05
Plain-language summary
This study will compare the medications fluoxetine (ProzacĀ®) and divalproex (DepakoteĀ®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
Who can participate
Age range21 Years ā 55 Years
SexALL
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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-neoplasticā¦
What they're measuring
1
Overt Aggression Scale-Modified for Outpatient Use (OAS-M)