A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
NCT ID: NCT00078754
Last Updated: 2021-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2003-05-31
2008-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
Participants will to receive treatment with fluoxetine for 12 weeks
Fluoxetine
Fluoxetine capsules by mouth, up to 60 mg daily
B
Participants will to receive treatment with divalproex for 12 weeks
Divalproex
Divalproex ER capsules by mouth, up to 3000 mg daily
C
Participants will to receive treatment with placebo for 12 weeks
Placebo
Placebo capsules by mouth, up to 8 capsules daily
Interventions
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Fluoxetine
Fluoxetine capsules by mouth, up to 60 mg daily
Divalproex
Divalproex ER capsules by mouth, up to 3000 mg daily
Placebo
Placebo capsules by mouth, up to 8 capsules daily
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
55 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Chicago
OTHER
Responsible Party
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Principal Investigators
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Emil F. Coccaro, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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The University of Chicago
Chicago, Illinois, United States
Countries
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Other Identifiers
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